A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Ulcerative Colitis (UC) Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819635
• Other study ID #: M14-234
• Secondary ID: 2016-000641-31
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 26, 2016
• Est. completion date: December 13, 2021

Study information

• Verified date: June 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

Description:

Substudy 1 was a Phase 2b dose-ranging study designed to evaluate the efficacy and safety of different oral doses of upadacitinib compared to placebo as 8-week induction therapy in participants with moderately to severely active UC. Approximately 250 participants were planned to be randomized 1:1:1:1:1 to the placebo group and 4 upadacitinib doses (7.5, 15, 30, and 45 mg). Randomization was stratified by previous biologic therapy use (yes/no), Baseline corticosteroid use (yes/no), and Baseline Adapted Mayo score (≤ 7 or > 7). The study duration included a Screening Period of up to 5 weeks and an 8-week double-blind (DB) Induction Period. After all randomized participants completed the 8-week induction, a dose-selection analysis of efficacy and safety (selected laboratory parameters) of upadacitinib versus placebo was performed. Based on this dose-selection analysis, one induction dose (upadacitinib 45 mg) was identified for further evaluation in two Phase 3 induction studies, M14-234 Substudy 2 and M14-675 (NCT03653026). During the analysis period, 132 additional participants were randomized into Groups 3 and 4 of Substudy 1 (upadacitinib 30 mg and 45 mg dose groups; approximately 66 participants per dose group). The objectives of enrolling these additional participants were to avoid interrupting the study activities during the analysis period and to support a sufficient number of participants with clinical response to be re-randomized into the maintenance portion in Substudy 3. Substudy 1 main participants are defined as those first 250 randomized 250, and additional participants are defined as those who were randomized after the main participants. Substudy 2 was a two-part Phase 3 dose-confirming study designed to evaluate the efficacy and safety of oral administration of upadacitinib 45 mg compared to placebo as induction therapy for up to 16 weeks in participants with moderately to severely active UC. Substudy 2 included a Screening Period of up to 5 weeks, Part 1, and Part 2. Part 1 was a randomized, DB, placebo-controlled 8-week induction period. Part 2 was an open-label, 8-week extended treatment period for clinical non-responders from Part 1 of Substudy 2. Part 1 was planned to enroll 462 subjects; actual enrollment was 474 subjects. Eligible participants were randomized in a 2:1 ratio to one of the two treatment groups (DB upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization was stratified by bio-IR status (Biologic inadequate responders [bio-IR] vs Non-biologic-inadequate responders [non-bio-IR], corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization was further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization was further stratified by previous biologic use (yes or no). Part 2 was an open label, 8-week Extended Treatment Period for those who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1. All participants received upadacitinib 45 mg. Substudy 3 was a Phase 3 maintenance study designed to evaluate the efficacy and safety of upadacitinib 15 and 30 mg once daily (QD) compared to placebo in achieving clinical remission per Adapted Mayo score in participants with moderately to severely active UC who achieved clinical response per Adapted Mayo score following induction therapy from Substudy 1, Substudy 2, or Study M14-675. A total of 1,046 subjects who achieved clinical response per Adapted Mayo score after completion of induction treatment or Extended Treatment Period in Study M14-234 Substudy 1, Substudy 2, or Study M14-675 entered Substudy 3, and 1,044 were treated with a blinded treatment assignment for up to 52 weeks. Substudy 3 included 4 cohorts. Cohort 1: 847 participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, and received upadacitinib 15, 30, or 45 mg QD. The treatment groups in Cohort 1 were Group 1: upadacitinib 15 mg QD; Group 2: upadacitinib 30 mg QD; and Group 3: placebo QD. Those who achieved clinical response and received upadacitinib 15 mg QD in Substudy 1 were re-randomized 1:1 to only receive upadacitinib 15 mg QD or placebo QD (treatment Group 1 or 3). Cohort 2: 104 participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3. Cohort 3: 75 participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 were re-randomized 1:1 and received blinded upadacitinib 30 mg QD or upadacitinib 15 mg QD in Substudy 3. Cohort 4: 20 participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1302
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

Note: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants =18 years old will be enrolled. Adolescents must weigh = 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.

• Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
• Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).
• Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator. Note: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.
• If female, participant must meet the criteria for Contraception Recommendations
• Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.

Exclusion Criteria:

• Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)
• Current diagnosis of fulminant colitis and/or toxic megacolon
• Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy
• Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline
• Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline
• Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
• Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
• Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Intervention

Drug:
• Placebo
Film-coated tablet for oral administration
• Upadacitinib
Film-coated tablet for oral administration

Locations

Country	Name	City	State
Argentina	Gedyt /ID# 210015	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 209495	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Mautalen Salud e Investigacion /ID# 171173	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 164185	Cordoba
Argentina	Cardio Alem /ID# 211280	San Isidro	Buenos Aires
Argentina	Sanatorio 9 de Julio /ID# 150189	San Miguel de Tucuman	Tucuman
Australia	Monash Medical Centre /ID# 150206	Clayton	Victoria
Australia	St Vincent's Hospital Melbourne /ID# 152472	Fitzroy Melbourne	Victoria
Australia	Macquarie University Hospital /ID# 211951	Macquarie University	New South Wales
Australia	Fiona Stanley Hospital /ID# 211640	Murdoch	Western Australia
Australia	Mater Misericordiae Limited /ID# 212685	South Brisbane	Queensland
Australia	Griffith University /ID# 211952	Southport	Queensland
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150305	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 150306	Salzburg
Austria	Klinik Landstrasse /ID# 162866	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 150614	Vienna	Wien
Belarus	Vitebsk Regional Advanced Clin /ID# 169612	???????
Belgium	AZ Maria Middelares /ID# 150331	Gent
Belgium	Universitair Ziekenhuis Leuven /ID# 150332	Leuven	Vlaams-Brabant
Belgium	AZ-Delta /ID# 150330	Roeselare
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 150209	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 150706	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Hospital Mostar /ID# 150705	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 150208	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla /ID# 150211	Tuzla	Tuzlanski
Brazil	Upeclin Fmb - Unesp /Id# 152485	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 152480	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153742	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 153743	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 152484	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 152481	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 152483	Sao Jose Do Rio Preto	Sao Paulo
Canada	University of Calgary /ID# 151821	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 211168	Edmonton	Alberta
Canada	Covenant Health /ID# 158930	Edmonton	Alberta
Canada	University of Alberta - Zeidler Ledcor Centre /ID# 151100	Edmonton	Alberta
Canada	CISSS de la Monteregie /ID# 159215	Greenfield Park	Quebec
Canada	Hamilton Health Sciences - McMaster University Medical Centre /ID# 150365	Hamilton	Ontario
Canada	Okanagan Clinical Trials /ID# 153178	Kelowna	British Columbia
Canada	CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150361	Levis	Quebec
Canada	Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167169	Montreal	Quebec
Canada	Recherche GCP Research /ID# 151822	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Centre /ID# 170012	Montréal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 151820	Ottawa	Ontario
Canada	CIUSSS de l'Estrie - CHUS /ID# 150366	Sherbrooke	Quebec
Canada	Medicor Research Inc /ID# 151101	Sudbury	Ontario
Canada	Toronto Digestive Disease Asso /ID# 150363	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 150367	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 212424	Concepción
Chile	CTR Estudios Clinicos /ID# 200110	Providencia
Chile	Hospital Clinico Universidad De Los Andes /ID# 207422	Santiago
Chile	M y F Estudios Clínicos /ID# 200107	Santiago	Region Metropolitana Santiago
Chile	Research Group /ID# 203176	Santiago	Region Metropolitana De Santiago
Chile	Centro de Investigaciones Clínicas Viña del Mar /ID# 150212	Viña del Mar	Valparaíso
China	The First Hospital of Jilin University /ID# 209986	Changchun	Jilin
China	Xiangya Hospital Central South University /ID# 167229	Changsha
China	West China Hospital, Sichuan University /ID# 167040	Chengdu
China	The First Affiliated Hospital, Sun Yat-sen University /ID# 150455	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 150456	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150454	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 165807	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 211750	Nanchang	Jiangxi
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165815	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150461	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital /ID# 150460	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 166920	Shenyang
China	Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216405	Shiyan	Hubei
China	Tianjin Medical University General Hospital /ID# 170604	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167088	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167078	Wuhan	Hubei
Colombia	Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 151564	Bogota DC	Cundinamarca
Colombia	Hospital Universitario de San /ID# 155387	Medellin
Colombia	Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207042	Monteria	Cordoba
Croatia	Duplicate_Klinicki bolnicki centar Osijek /ID# 150216	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Rijeka /ID# 150708	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 213988	Split	Splitsko-dalmatinska Zupanija
Croatia	Zadar General Hospital /ID# 150221	Zadar
Croatia	Clinical Hospital Dubrava /ID# 150213	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 150225	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 150709	Zagreb	Grad Zagreb
Croatia	Poliklinika Solmed /ID# 211483	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 150912	Hradec Kralove
Czechia	CTCenter MaVe s.r.o. /ID# 150904	Olomouc
Czechia	ARTROSCAN s.r.o. /ID# 150401	Ostrava
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 213539	Pardubice
Czechia	Axon Clinical, s.r.o. /ID# 152479	Praha
Czechia	ISCARE a.s. /ID# 209278	Praha
Czechia	Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216221	Praha
Estonia	East Tallinn Central Hospital /ID# 150417	Kesklinna Linnaosa	Harjumaa
Estonia	North Estonia Medical Centre /ID# 160870	Mustamäe Linnaosa	Harjumaa
Estonia	West Tallinn Central Hospital /ID# 150419	Tallinn
Estonia	Tartu University Hospital /ID# 150418	Tartu Linn	Tartumaa
Finland	Duplicate_Helsinki Univ Central Hospital /ID# 150407	Helsinki
Finland	Keski-Suomen Sairaala Nova /ID# 155666	Jyvaskyla
Finland	Laakarikeskus Ikioma /ID# 150121	Mikkeli
Finland	Tampere University Hospital /ID# 150114	Tampere	Pirkanmaa
Finland	Turku University Hospital /ID# 168301	Turku
France	CHU Amiens-Picardie Site Sud /ID# 163456	Amiens CEDEX 1	Somme
France	CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 154452	La Roche Sur Yon
France	CHRU Lille - Hopital Claude Huriez /ID# 152607	Lille	Hauts-de-France
France	CHU Hopital Nord /ID# 163508	Marseille	Bouches-du-Rhone
France	CHU Montpellier - Hôpital Saint Eloi /ID# 200006	Montpellier Cedex 5	Herault
France	Chu de Nice-Hopital L'Archet Ii /Id# 152606	Nice	Alpes-Maritimes
France	HCL - Hôpital Lyon Sud /ID# 152539	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	CHU de Saint-Etienne, Hopital Nord /ID# 154453	SAINT-ETIENNE Cedex 1
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 150766	Berlin
Germany	Agaplesion Markus Krankenhaus /ID# 161982	Frankfurt am Main
Germany	Gastroenterologische Gemeinschaftspraxis Herne /ID# 214574	Herne	Nordrhein-Westfalen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161981	Kiel	Schleswig-Holstein
Germany	Universitatsklinikum Mannheim /ID# 150173	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 207135	Muenster
Germany	Universitatsklinikum Munster /ID# 150158	Munster	Niedersachsen
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215811	Saarbrücken	Saarland
Germany	Universitaetsklinimum Tuebingen /ID# 150767	Tubingen	Baden-Wuerttemberg
Germany	Praxis medicum /ID# 150166	Wiesbaden
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150309	Athens
Greece	General Hospital of Athens Laiko /ID# 208669	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202100	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 150250	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 164248	Ioannina
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 209521	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 163896	Thessaloniki
Hungary	Bekes Megyei Kozponti Korhaz /ID# 151572	Bekescsaba
Hungary	Semmelweis Egyetem /ID# 150312	Budapest
Hungary	Meditres Kft. /ID# 151521	Kecskemet
Hungary	Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151523	Sopron
Hungary	Mentahaz Maganorvosi Kozpont /ID# 205884	Szekesfehervar
Hungary	Markusovszky Egyetemi Oktatokorhaz /ID# 150313	Szombathely	Vas
Ireland	Beaumont Hospital /ID# 150321	Beaumont	Dublin
Ireland	Mercy University Hospital /ID# 151529	Cork
Ireland	St James Hospital /ID# 150320	Dublin 8	Dublin
Ireland	St Vincent's University Hospital /ID# 150318	Elm Park	Dublin
Ireland	University Hospital Galway /ID# 150319	Galway
Israel	Soroka University Medical Center /ID# 156561	Be'er Sheva	HaDarom
Israel	Rambam Health Care Campus /ID# 150325	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 165118	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 161677	Jerusalem
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150337	Bologna
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150334	Milan
Italy	ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150602	Milano
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201725	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150253	Palermo
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216610	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 151360	Rome	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 150338	Rome	Roma
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150333	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 151361	Rozzano	Milano
Japan	Tokatsu Tsujinaka Hospital /ID# 214962	Abiko-shi	Chiba
Japan	Asahikawa Medical University Hospital /ID# 170289	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 152016	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital /ID# 152628	Chikushino-shi	Fukuoka
Japan	St.Luke's International Hospital /ID# 208074	Chuo-ku	Tokyo
Japan	Fukui Prefectural Hospital /ID# 210448	Fukui-shi	Fukui
Japan	Kyushu University Hospital /ID# 152526	Fukuoka-shi	Fukuoka
Japan	Saiseikai Fukuoka Genaral Hospital /ID# 209479	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 206293	Fukuyama-shi	Hiroshima
Japan	Tokai University Hachioji Hospital /ID# 152587	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 205708	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Mito Medical Center /ID# 152631	Higashi Ibaraki-gun	Ibaraki
Japan	National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210709	Higashi-ohmi-shi	Shiga
Japan	Hirosaki National Hospital /ID# 152763	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 151951	Hiroshima-shi	Hiroshima
Japan	Teikyo University Hospital /ID# 208897	Itabashi-ku	Tokyo
Japan	Shimane University Hospital /ID# 208899	Izumo-shi	Shimane
Japan	Idzuro Imamura Hospital /ID# 206024	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 227134	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital /ID# 206672	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 205099	Kanazawa-shi	Ishikawa
Japan	Tsujinaka Hospital Kashiwanoha /ID# 209130	Kashiwa-shi	Chiba
Japan	Saitama Medical Center /ID# 152031	Kawagoe-shi	Saitama
Japan	St. Marianna University School of Medicine Hospital /ID# 208654	Kawasaki-shi	Kanagawa
Japan	Kitakyushu Municipal Med Ctr /ID# 152588	Kitakyushu	Fukuoka
Japan	Aoyama Clinic /ID# 152049	Kobe-shi	Hyogo
Japan	Yamanashi Prefectural Central Hospital /ID# 151908	Kofu-shi	Yamanashi
Japan	Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157821	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 151976	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hosital /ID# 152359	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 211758	Kyoto-shi	Kyoto
Japan	Kitasato University Kitasato Institute Hospital /ID# 152686	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 153194	Mitaka-shi	Tokyo
Japan	Iwate Medical University Uchimaru Medical Center /ID# 203411	Morioka-shi	Iwate
Japan	Aichi Medical University Hospital /ID# 151993	Nagakute-shi	Aichi
Japan	Nagoya City University Hospital /ID# 151950	Nagoya shi	Aichi
Japan	Nagoya University Hospital /ID# 152709	Nagoyashi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 218048	Niigata-shi	Niigata
Japan	Saiseikai Niigata Hospital /ID# 209916	Niigata-shi	Niigata
Japan	Hyogo College of Medicine College Hospital /Id# 152434	Nishinomiya-shi	Hyogo
Japan	Obihiro kosei Hospital /ID# 210412	Obihiro-shi	Hokkaido
Japan	Ogaki Municipal Hospital /ID# 208225	Ogaki-shi	Gifu
Japan	Ishida Clinic of IBD and Gastroenterology /ID# 210117	Oita-shi	Oita
Japan	Okayama University Hospital /ID# 217923	Okayama-shi	Okayama
Japan	NHO Nagasaki Medical Center /ID# 209531	Omura-shi	Nagasaki
Japan	Japanese Red Cross Osaka Hospital /ID# 209476	Osaka-shi	Osaka
Japan	Kinshukai Infusion Clinic /ID# 207864	Osaka-shi	Osaka
Japan	Kitano Hospital /ID# 210395	Osaka-shi	Osaka
Japan	Osaka City General Hospital /ID# 152704	Osaka-shi	Osaka
Japan	Osaka City University Hospital /ID# 152682	Osaka-shi	Osaka
Japan	Saga University Hospital /ID# 209268	Saga-shi	Saga
Japan	Tokitokai Tokito clinic /ID# 152677	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 151936	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151506	Sapporo-shi	Hokkaido
Japan	Sapporo Higashi Tokushukai Hospital /ID# 208487	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 206492	Sapporo-shi	Hokkaido
Japan	Sapporo Tokushukai Hospital /ID# 209397	Sapporo-shi	Hokkaido
Japan	National Hospital Organization Sendai Medical Center /ID# 209527	Sendai-shi	Miyagi
Japan	Center Hospital of the National Center for Global Health and Medicine /ID# 209267	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital /ID# 205977	Shinjuku-ku	Tokyo
Japan	Tokuyama Central Hospital /ID# 216993	Shunan-shi	Yamaguchi
Japan	NHO Shizuoka Medical Center /ID# 163572	Sunto-gun	Shizuoka
Japan	Shoyukai Fujita Gastroenterological Hospital /ID# 216492	Takatsuki-shi
Japan	Toyohashi Municipal Hospital /ID# 171457	Toyohashi-shi	Aichi
Japan	Toyonaka Municipal Hospital /ID# 217079	Toyonaka-shi	Osaka
Japan	Ieda Hospital /ID# 157781	Toyota-shi	Aichi
Japan	Mie University Hospital /ID# 205362	Tsu-shi	Mie
Japan	Juntendo University Urayasu Hospital /ID# 208781	Urayasu-shi	Chiba
Japan	Yamagata University Hospital /ID# 171454	Yamagata-shi	Yamagata
Japan	Kenseikai Dongo Hospital /ID# 208100	Yamatotakada-shi	Nara
Japan	Yokkaichi Hazu Medical Center /ID# 214347	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 169899	Yokohama shi	Kanagawa
Japan	Showa University Fujigaoka Hospital /ID# 208222	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 159480	Busan
Korea, Republic of	Pusan National University Hospital /ID# 159481	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 150345	Daegu
Korea, Republic of	Hayang University GuriHospital /ID# 150344	Guri	Gyeonggido
Korea, Republic of	CHA University Bundang Medical Center /ID# 159479	Seongnam si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 150900	Seoul
Korea, Republic of	Kangbuk Samsung Hospital /ID# 150348	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 150346	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 159478	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital /ID# 150347	Suwon	Gyeonggido
Latvia	Pauls Stradins Clinical University Hospital /ID# 151409	Riga
Latvia	Riga East Clinical University Hospital /ID# 150354	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150357	Kaunas
Lithuania	Klaipeda Seamens Hospital /ID# 154319	Klaipeda
Lithuania	Klaipeda University Hospital /ID# 158862	Klaipeda
Lithuania	Vilnius University Hospital /ID# 154318	Vilnius
Malaysia	Hospital Sultanah Bahiyah /ID# 151687	Alor Setar	Kedah
Malaysia	Hospital Ampang /ID# 151298	Ampang
Malaysia	Uni Malaya MC /ID# 150359	Kuala Lumpur
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 151689	Kuala Lumpur	Selangor
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 150710	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 211325	Leon	Guanajuato
Mexico	Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150256	Monterrey	Nuevo Leon
Netherlands	Academisch Medisch Centrum /ID# 150647	Amsterdam
Netherlands	Leids Universitair Medisch Centrum /ID# 152624	Leiden
Netherlands	Radboud Universitair Medisch Centrum /ID# 151700	Nijmegen	Gelderland
Netherlands	Erasmus Medisch Centrum /ID# 150308	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht /ID# 152775	Utrecht
Norway	Akershus universitetssykehus /ID# 150317	Nordbyhagen	Akershus
Norway	Universitetssykehuset Nord-Norge /ID# 152835	Tromsø	Troms
Poland	Endoskopia Sp. z o.o. /ID# 150765	Sopot	Pomorskie
Poland	Gastromed /Id# 216197	Torun	Kujawsko-pomorskie
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 150580	Warszawa	Mazowieckie
Poland	Centrum Medyczne Reuma Park /ID# 150349	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 150351	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215732	Warszawa	Mazowieckie
Poland	NZOZ Vivamed /ID# 216742	Warszawa	Mazowieckie
Portugal	Hospital Garcia de Orta, EPE /ID# 151613	Almada
Portugal	CCA Braga - Hospital de Braga /ID# 151608	Braga
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151607	Guimaraes	Braga
Portugal	Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151606	Lisboa
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 151611	Lisboa
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151609	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151610	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 152335	Santa Maria Da Feira	Porto
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150358	San Juan
Russian Federation	Immanuel Kant Baltic Federal University /ID# 200719	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 166042	Kazan	Tatarstan, Respublika
Russian Federation	City Clinical Hospital #24 /ID# 150395	Moscow
Russian Federation	Olla-Med Clinic /ID# 215332	Moscow
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150386	Perm	Permskiy Kray
Russian Federation	Republican hospital named after V.A. Baranov /ID# 206506	Petrozavodsk
Russian Federation	Euromedservice /ID# 203800	Pushkin
Russian Federation	LLC Novaya Klinika /ID# 208107	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Medical Company Hepatolog /ID# 200197	Samara	Samarskaya Oblast
Russian Federation	NW State Medical Univ na Mechn /ID# 169322	St. Petersburg	Leningradskaya Oblast
Russian Federation	Duplicate_Stavropol State Medical Univ /ID# 150387	Stavropol
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 150426	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 150427	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 150429	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 150428	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 150430	Kragujevac	Sumadijski Okrug
Serbia	General Hospital Leskovac /ID# 217880	Leskovac
Serbia	University Clinical Center of Nis /ID# 151903	NIS	Nisavski Okrug
Serbia	Clinical Center Vojvodina /ID# 150764	Novi Sad	Vojvodina
Singapore	Gleneagles Medical Centre /ID# 206018	Singapore
Singapore	National University Hospital /ID# 150453	Singapore
Singapore	Tan Tock Seng Hospital /ID# 150443	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150868	Banska Bystrica
Slovakia	Medak s.r.o. /ID# 150480	Bratislava
Slovakia	Slovak Research Center Team Me /ID# 150257	Ilava
Slovakia	B+B MED, s.r.o. /ID# 150471	Kosice
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211370	Nove Zamky
Slovakia	GASTRO I., s.r.o. /ID# 150472	Presov
South Africa	MD Search /ID# 167293	Boksburg North	Gauteng
South Africa	Kingsbury Hospital /ID# 150497	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 155144	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 162202	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 163622	Johannesburg	Gauteng
South Africa	Lenasia Clinical Trial Centre /ID# 214344	Johannesburg	Gauteng
South Africa	Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 150785	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 150496	Johannesburg	Gauteng
Spain	Hospital Universitario A Coruna - CHUAC /ID# 203911	A Coruna
Spain	Hospital Clinic de Barcelona /ID# 150612	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 151066	Cordoba
Spain	Hospital Universitario Dr. Negrin /ID# 203937	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario La Paz /ID# 214539	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 151067	Madrid
Spain	Hospital Universitario de Salamanca /ID# 150509	Salamanca
Spain	Hospital Unversitario Marques de Valdecilla /ID# 216620	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 151065	Santiago de Compostela	A Coruna
Spain	Hospital Universitario y Politecnico La Fe /ID# 150611	Valencia
Sweden	Sahlgrenska University Hospital /ID# 151496	Gothenburg	Vastra Gotalands Lan
Switzerland	Universitätsspital Basel /ID# 161731	Basel	Basel-Stadt
Switzerland	Inselspital, Universitätsspital Bern /ID# 152590	Bern
Switzerland	Kantonsspital St. Gallen /ID# 152599	St. Gallen	Sankt Gallen
Switzerland	Universitätsspital Zürich /ID# 152591	Zürich	Zuerich
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575	Kaohsiung
Taiwan	Chung Shan Medical University Hospital /ID# 150573	Taichung
Taiwan	China Medical University Hospital /ID# 150571	Taichung City
Taiwan	National Cheng Kung University Hospital /ID# 151749	Tainan
Taiwan	National Taiwan University Hospital /ID# 150574	Taipei City
Taiwan	Taipei Veterans General Hosp /ID# 151748	Taipei City
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 150125	Istanbul
Turkey	Marmara University Medical Fac /ID# 213969	Istanbul
Turkey	Umraniye Training and Res Hosp /ID# 162659	Istanbul
Turkey	Erciyes University Medical Fac /ID# 150129	Melikgazi	Kayseri
Turkey	Mersin University Medical /ID# 157849	Mersin
Turkey	Gazi Universitesi Tip Fakultes /ID# 150127	Yenimahalle
Ukraine	Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207723	Dnipro
Ukraine	CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206940	Kharkiv
Ukraine	PE PMC Acinus, Medical and Diagnostic Center /ID# 217216	Kropyvnytskyi
Ukraine	CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217372	Kyiv
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 150372	Kyiv
Ukraine	Medical Center CONSILIUM MEDICAL /ID# 217446	Kyiv
Ukraine	Lviv Regional Clinical Hospital /ID# 150375	Lviv
Ukraine	Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 151275	Odesa
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216297	Vinnytsia
Ukraine	Medical Center of the "Health /ID# 151274	Vinnytsya	Vinnytska Oblast
United Kingdom	Hampshire Hospitals NHS Foundation Trust /ID# 150380	Basingstoke	Essex
United Kingdom	Royal United Hospitals Bath /ID# 151532	Bath
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 150382	Birmingham
United Kingdom	Royal Devon and Exeter NHS Trust Hospital /ID# 150379	Exeter	Devon
United Kingdom	NHS Greater Glasgow and Clyde /ID# 163787	Glasgow	Scotland
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust /ID# 217658	Huddersfield
United Kingdom	Barts Health NHS Trust /ID# 150384	London	London, City Of
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 208374	Tooting
United States	Duplicate_University of New Mexico Department of Internal Medicine /ID# 214396	Albuquerque	New Mexico
United States	Huron Gastroenterology Assoc /ID# 152710	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151140	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 151526	Arlington	Texas
United States	Digestive Health Partners, P.A /ID# 167237	Asheville	North Carolina
United States	University of Maryland Med Ctr /ID# 150449	Baltimore	Maryland
United States	Inquest Clinical Research /ID# 164635	Baytown	Texas
United States	Washington Gastroenterology /ID# 163629	Bellevue	Washington
United States	Birmingham Gastroenterology Associates P.C /ID# 151276	Birmingham	Alabama
United States	Massachusetts General Hospital /ID# 165676	Boston	Massachusetts
United States	HP Clinical Research /ID# 163939	Bountiful	Utah
United States	Advantage Clinical Trials /ID# 163938	Bronx	New York
United States	Montefiore Medical Center - Moses Campus /ID# 150543	Bronx	New York
United States	NY Scientific /ID# 152707	Brooklyn	New York
United States	Texas Digestive Disease Consultants /ID# 209804	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209947	Cedar Park	Texas
United States	Delsol Research Management, Ll /Id# 170131	Chandler	Arizona
United States	Pharmacorp Clinical Trials /ID# 153354	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 156971	Charlotte	North Carolina
United States	Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 153027	Chesterfield	Michigan
United States	Next Innovative Clinical Research - Chicago /ID# 216060	Chicago	Illinois
United States	The University of Chicago DCAM /ID# 150547	Chicago	Illinois
United States	Consultants for Clinical Research /ID# 151679	Cincinnati	Ohio
United States	University of Cincinnati /ID# 164582	Cincinnati	Ohio
United States	Gastro Florida /ID# 155245	Clearwater	Florida
United States	Delta Waves, Inc. /ID# 151721	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 200022	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 169696	Columbus	Ohio
United States	The Ohio State University /ID# 169416	Columbus	Ohio
United States	Citrus Valley Gastroenterology /ID# 151914	Covina	California
United States	Tri-State Gastroenterology /ID# 169811	Crestview Hills	Kentucky
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200770	Dallas	Texas
United States	Western Connecticut Medical Group /ID# 169210	Danbury	Connecticut
United States	Hometown Urgent Care and Resea /ID# 200065	Dayton	Ohio
United States	Moonshine Research Center, Inc /ID# 152533	Doral	Florida
United States	Universal Axon Clinical Research /ID# 213461	Doral	Florida
United States	AGA Clinical Research Associates, LLC /ID# 153040	Egg Harbor Township	New Jersey
United States	Dayton Gastroenterology, Inc. /ID# 167631	Englewood	Ohio
United States	NorthShore University HealthSystem /ID# 150555	Evanston	Illinois
United States	MediSphere Medical Research Center /ID# 152064	Evansville	Indiana
United States	Plains Clinical Research Center, LLC /ID# 170290	Fargo	North Dakota
United States	Ctr for Gastrointestinal Healt /ID# 153360	Franklin	Virginia
United States	DHAT Research Institute /ID# 151218	Garland	Texas
United States	Gastro One /ID# 151144	Germantown	Tennessee
United States	Aurora Medical Center - Grafto /ID# 151717	Grafton	Wisconsin
United States	NYU Langone Long Island Clinical Research Association /ID# 155272	Great Neck	New York
United States	Atlantic Gastroenterology Clinical Research /ID# 151899	Greenville	North Carolina
United States	Gastroenterology Associates, P.A. of Greenville /ID# 150541	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 150482	Hamden	Connecticut
United States	Palmetto Research, LLC /ID# 151716	Hialeah	Florida
United States	Northwest Health Care Associates /ID# 151590	Hoffman Estates	Illinois
United States	Houma Digestive Health Special /ID# 151844	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 150486	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201216	Houston	Texas
United States	CliniCore International, LLC /ID# 152062	Houston	Texas
United States	GI Specialists of Houston /ID# 202327	Houston	Texas
United States	Vilo Research Group Inc /ID# 212624	Houston	Texas
United States	Newport Huntington Medical Group /ID# 217005	Huntington Beach	California
United States	Indianapolis Gastroenterology /ID# 162901	Indianapolis	Indiana
United States	Nature Coast Clinical Research - Inverness /ID# 154064	Inverness	Florida
United States	University of Iowa Hospitals and Clinics /ID# 157058	Iowa City	Iowa
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 170712	Jackson	Mississippi
United States	University of Mississippi Medical Center /ID# 213139	Jackson	Mississippi
United States	Encore Borland-Groover Clinical Research /Id# 170912	Jacksonville	Florida
United States	East Tennessee Research Institute /ID# 203610	Johnson City	Tennessee
United States	SIH Research Mumtaz, Inc /ID# 163319	Kissimmee	Florida
United States	UC San Diego Health System /ID# 155185	La Jolla	California
United States	Las Vegas Medical Research /ID# 153044	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center /ID# 150549	Lebanon	New Hampshire
United States	Emeritas Research Group, LLC /ID# 150258	Leesburg	Virginia
United States	South Denver Gastroenterology /ID# 151223	Lone Tree	Colorado
United States	United Medical Doctors /ID# 207464	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080	Los Angeles	California
United States	TLC Clinical Research Inc /ID# 216829	Los Angeles	California
United States	Caprock Gastro Research, LLC /ID# 214754	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 165782	Macon	Georgia
United States	Cfagi Llc /Id# 202017	Maitland	Florida
United States	Great Lakes Medical Research, LLC /ID# 201772	Mentor	Ohio
United States	Ohio Clinical Research Partner /ID# 154068	Mentor	Ohio
United States	Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885	Mesa	Arizona
United States	Advanced Pharma /ID# 151719	Miami	Florida
United States	Coral Research Clinic /ID# 150444	Miami	Florida
United States	Crystal Pharmacology Research /ID# 151841	Miami	Florida
United States	New Horizon Research Center /ID# 152474	Miami	Florida
United States	University of Miami /ID# 215441	Miami	Florida
United States	Medical College of Wisconsin /ID# 151843	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 151838	Milwaukee	Wisconsin
United States	Facey Medical Foundation /ID# 203133	Mission Hills	California
United States	CB Flock Research Corporation /ID# 165980	Mobile	Alabama
United States	East View Medical Research, LLC /ID# 171183	Mobile	Alabama
United States	Atlantic Digestive Health Inst /ID# 150447	Morristown	New Jersey
United States	United Medical Doctors - Murrieta /ID# 151211	Murrieta	California
United States	Quality Medical Research /ID# 203426	Nashville	Tennessee
United States	Vanderbilt University Medical Center /ID# 153355	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson /ID# 155248	New Brunswick	New Jersey
United States	Nola Research Works, LLC /ID# 153356	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 163098	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 163410	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 201533	North Massapequa	New York
United States	Advanced Research Institute /ID# 162624	Ogden	Utah
United States	Digestive Disease Specialists /ID# 201056	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 216337	Oklahoma City	Oklahoma
United States	Endoscopic Research, Inc. /ID# 151720	Orlando	Florida
United States	Omega Research Maitland, LLC /ID# 200269	Orlando	Florida
United States	InSite Digestive Health Care - Oxnard /ID# 163414	Oxnard	California
United States	Northwest Gastroenterology Clinic /ID# 152527	Portland	Oregon
United States	Premier Medical Group - GI Division /ID# 153357	Poughkeepsie	New York
United States	Inland Empire Clinical Trials, LLC /ID# 216038	Rialto	California
United States	Infinite Clinical Trials /ID# 215340	Riverdale	Georgia
United States	Gastoenterology Group of Rochester /ID# 151079	Rochester	New York
United States	Mayo Clinic - Rochester /ID# 151677	Rochester	Minnesota
United States	Washington University-School of Medicine /ID# 150485	Saint Louis	Missouri
United States	Minnesota Gastroenterology PA /ID# 151678	Saint Paul	Minnesota
United States	Utah Gastroenternology - St. Mark's Office /ID# 163101	Salt Lake City	Utah
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 201260	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 169396	San Antonio	Texas
United States	Medical Assoc Research Grp /ID# 169148	San Diego	California
United States	San Diego Clinical Trials /ID# 212120	San Diego	California
United States	Univ of California San Francis /ID# 164581	San Francisco	California
United States	Guthrie Medical Group, PC /ID# 150481	Sayre	Pennsylvania
United States	The Polyclinic /ID# 164369	Seattle	Washington
United States	Virginia Mason Medical Center /ID# 153026	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 150446	Shreveport	Louisiana
United States	Revival Research Institute, LLC /ID# 207280	Southfield	Michigan
United States	Penn State Health Colonnade /ID# 150259	State College	Pennsylvania
United States	Richmond University Medical Center /ID# 201859	Staten Island	New York
United States	Carl R. Meisner Medical Clinic /ID# 171061	Sugar Land	Texas
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822	Sun City	Arizona
United States	Atlanta Gastroenterology Spec /ID# 150548	Suwanee	Georgia
United States	AdventHealth Tampa /ID# 200272	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 201790	Tampa	Florida
United States	University of South Florida /ID# 214493	Tampa	Florida
United States	Baylor Scott & White Center for Diagnostic Medicine /ID# 204499	Temple	Texas
United States	Cotton-O'Neil Clinical Res Ctr /ID# 167182	Topeka	Kansas
United States	Center for Digestive Health /ID# 161984	Troy	Michigan
United States	Adobe Clinical Research LLC /ID# 155250	Tucson	Arizona
United States	University of Arizona /ID# 150553	Tucson	Arizona
United States	Healthcare Research Consultant /ID# 163100	Tulsa	Oklahoma
United States	Options Health Research, LLC /ID# 150554	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 169146	Tyler	Texas
United States	Carle Foundation Hospital /ID# 151137	Urbana	Illinois
United States	The Vancouver Clinic, INC. PS /ID# 162333	Vancouver	Washington
United States	Gastro Health & Nutrition - Victoria /ID# 167761	Victoria	Texas
United States	Velocity Clinical Research - Salt Lake City /ID# 163181	West Jordan	Utah
United States	Western States Clinical Res /ID# 158076	Wheat Ridge	Colorado
United States	Clinical Trials of America /ID# 153448	Winston-Salem	North Carolina
United States	Wake Forest Baptist Medical Center /ID# 150448	Winston-Salem	North Carolina
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157484	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.; For Substudy 1, clinical remission is defined as SFS = 1, RBS of 0, and endoscopic subscore = 1.	At Week 8
Primary	Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.; For Substudy 2, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.	At Week 8
Primary	Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.; For Substudy 3, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.	At Week 52
Secondary	Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8	Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 8
Secondary	Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score = 2 and no individual subscore > 1.	At Week 8
Secondary	Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score = 2 points and = 30% from baseline, and a decrease in RBS = 1 or an absolute RBS = 1).	At Week 8
Secondary	Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2	The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.; Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score = 2 points and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.	At Week 2
Secondary	Substudy 1: Change in Full Mayo Score From Baseline to Week 8	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score = 2 and no individual subscore > 1.	Baseline (Week 0), Week 8
Secondary	Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8	Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 8
Secondary	Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8	The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.; Histologic improvement was defined as decrease from baseline in Geboes score.	At Week 8
Secondary	Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8	Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 8
Secondary	Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8	Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 8
Secondary	Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score = 2 points and = 30% from baseline, and a decrease in RBS = 1 or an absolute RBS = 1).	At Week 8
Secondary	Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2	The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.; Clinical response per Partial Mayo Score is defined as a decrease from Baseline = 1 point and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.	At Week 2
Secondary	Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8	Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score = 3.1.; The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).; The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	At Week 8
Secondary	Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8	Bowel urgency was assessed by participants in a subject diary completed once a day.	At Week 8
Secondary	Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8	Abdominal pain was assessed by participants in a subject diary completed once a day.	At Week 8
Secondary	Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8	The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.	At Week 8
Secondary	Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8	The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.	Baseline (Week 0), Week 8
Secondary	Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8	Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).; The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	At Week 8
Secondary	Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8	The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.	Baseline (Week 0), Week 8
Secondary	Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52	Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 52
Secondary	Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.; For Substudy 3, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.	At Week 52
Secondary	Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for = 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.; For Substudy 3, clinical remission is defined as SFS = 1 and not greater than Baseline, RBS of 0, and endoscopic subscore = 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.	At Week 52
Secondary	Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment	Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 52
Secondary	Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52	Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).	At Week 52
Secondary	Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment	The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).; Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).; Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score = 2 points and = 30% from baseline, and a decrease in RBS = 1 or an absolute RBS = 1).	At Week 52
Secondary	Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52	Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score = 3.1.; The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).; The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	At Week 52
Secondary	Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52	The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.	Baseline (Week 0), Week 52
Secondary	Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52	Mucosal healing is defined as an endoscopic score of 0 and Geboes score < 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).; The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.	At Week 52
Secondary	Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52	Bowel urgency was assessed by participants in a subject diary completed once a day.	At Week 52
Secondary	Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52	Abdominal pain was assessed by participants in a subject diary completed once a day.	At Week 52
Secondary	Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52	The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.	Baseline (Week 0), Week 52

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