A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC) Clinical Trial

— U-Accomplish  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653026
• Other study ID #: M14-675
• Secondary ID: 2016-000642-62
• Status: Completed
• Phase: Phase 3
• Start date: December 6, 2018
• Est. completion date: January 14, 2021

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Description:

Study M14-675 consists of 2 parts, Part 1 and Part 2. Part 1 is a randomized, double-blind, placebo-controlled 8-week induction period. Part 2 is an open-label, 8-week extended treatment period for participants who did not achieve clinical response at Week 8 in Part 1.

Eligible participants are randomized in a 2:1 ratio to one of the two treatment groups (upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization is stratified by biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization is further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization is further stratified by previous biologic use (yes or no).

Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16 and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234 Substudy 3 (NCT02819635; 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068; long-term follow-up study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female participants = 16 and = 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh = 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.

• Diagnosis of Ulcerative Colitis (UC) 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 UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.

• Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

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 as defined above.

• 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.

• If female, participant must meet the contraception recommendation criteria.

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 who received azathioprine or 6-mercaptopurine (6-MP) 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 prespecified abnormal hematologic results.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
Tablet for oral administration
• Upadacitinib
Tablet for oral administration

Locations

Country	Name	City	State
Argentina	Gedyt /ID# 210017	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 209497	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Mautalen Salud e Investigacion /ID# 206033	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 206030	Cordoba
Argentina	Cardio Alem /ID# 211282	San Isidro	Buenos Aires
Australia	St Vincent's Hospital Melbourne /ID# 205758	Fitzroy	Victoria
Australia	Macquarie University Hospital /ID# 211955	Macquarie University	New South Wales
Australia	Monash Medical Centre /ID# 206486	Melbourne	Victoria
Australia	Fiona Stanley Hospital /ID# 211642	Murdoch	Western Australia
Australia	Duplicate_Mater Misericordiae /ID# 212687	South Brisbane	Queensland
Australia	Griffith University /ID# 211956	Southport	Queensland
Austria	LKH Salzburg and Paracelsus /ID# 208788	Salzburg
Austria	Klinik Landstrasse /ID# 205764	Vienna	Wien
Austria	Medical University of Vienna /ID# 205763	Vienna	Wien
Belgium	AZ Maria Middelares /ID# 210928	Gent
Belgium	Universitair Ziekenhuis Leuven /ID# 205988	Leuven	Vlaams-Brabant
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 208053	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 208055	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Hospital Mostar /ID# 208054	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 208058	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla /ID# 208057	Tuzla	Tuzlanski
Brazil	Upeclin Fmb - Unesp /Id# 206986	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 206981	Curitiba	Parana
Brazil	Hospital de Clinicas de Porto Alegre /ID# 206985	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 206504	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 206984	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 206982	Sao Jose Do Rio Preto	Sao Paulo
Canada	University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 205755	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 211167	Edmonton	Alberta
Canada	Covenant Health /ID# 205500	Edmonton	Alberta
Canada	Crchum /Id# 207387	Montreal	Quebec
Canada	CIUSSS de l'Estrie - CHUS /ID# 205499	Sherbrooke	Quebec
Canada	Duplicate_Toronto Digestive Disease Asso /ID# 205498	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 205501	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 212426	Concepción
Chile	CTR Estudios Clinicos /ID# 208036	Providencia
Chile	Hospital Clinico Universidad De Los Andes /ID# 207426	Santiago
Chile	M y F Estudios Clínicos Ltda. /ID# 208035	Santiago	Region Metropolitana De Santiago
Chile	Research Group /ID# 208037	Santiago	Region Metropolitana De Santiago
China	The First Hospital of Jilin University /ID# 210088	Changchun	Jilin
China	West China Hospital, Sichuan University /ID# 205332	Chengdu
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205267	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 205268	Guangzhou	Guangdong
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 205271	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 212186	Nanchang	Jiangxi
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 205333	Shanghai	Shanghai
China	Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216406	Shiyan	Hubei
China	Duplicate_Tianjin Med Univ General Hosp /ID# 205246	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 205265	Wuhan
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 205266	Wuhan	Hubei
Colombia	Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 208886	Bogota DC	Cundinamarca
Colombia	Hospital Universitario San Vic /ID# 208888	Medellin
Colombia	Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 208887	Monteria	Cordoba
Croatia	Klinicki bolnicki centar Rijeka /ID# 208650	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 217027	Split
Croatia	Klinicka bolnica Dubrava Zagreb /ID# 208460	Zagreb	Grad Zagreb
Croatia	Poliklinika Solmed /ID# 211568	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 205672	Hradec Kralove
Czechia	CTCenter MaVe s.r.o. /ID# 205671	Olomouc
Czechia	Artroscan s.r.o. /ID# 205668	Ostrava
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 213540	Pardubice
Czechia	Axon Clinical, s.r.o. /ID# 205670	Praha
Czechia	ISCARE a.s. /ID# 209240	Praha
Czechia	Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216223	Praha
Estonia	East Tallinn Central Hospital /ID# 207564	Tallinn	Harjumaa
Estonia	North Estonia Medical Centre /ID# 207357	Tallinn
Estonia	West Tallinn Central Hospital /ID# 207356	Tallinn
Estonia	Tartu University Hospital /ID# 212282	Tartu
Finland	Keski-Suomen Sairaala Nova /ID# 206159	Jyvaskyla
Finland	Laakarikeskus Ikioma /ID# 205814	Mikkeli
Finland	Tampere University Hospital /ID# 206161	Tampere	Pirkanmaa
Finland	Tyks /Id# 205813	Turku
France	Chu de Nice-Hopital L'Archet Ii /Id# 209118	Nice CEDEX 3	Alpes-Maritimes
France	Centre Hospitalier Lyon Sud /ID# 209121	Pierre Benite CEDEX	Rhone
Germany	Duplicate_Praxis am Bayrischen Platz /ID# 206733	Berlin
Germany	Agaplesion Markus Krankenhaus /ID# 206731	Frankfurt am Main
Germany	Gastroenterologische Gemeinschaftspraxis Herne /ID# 214576	Herne	Nordrhein-Westfalen
Germany	Duplicate_Univ Hosp Schleswig-Holstein /ID# 206791	Kiel
Germany	Universitatsklinikum Mannheim /ID# 206811	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 207137	Muenster
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215813	Saarbrücken	Saarland
Germany	Duplicate_Universitaetsklinikum Tuebingen /ID# 206737	Tübingen	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 206332	Athens
Greece	General Hospital of Athens Laiko /ID# 208671	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 207061	Heraklion	Kriti
Greece	Duplicate_General Hospital of Thessaloniki Hippokrateio /ID# 208822	Thessaloniki
Hungary	Bekes Megyei Kozponti Korhaz /ID# 205885	Bekescsaba
Hungary	Semmelweis Egyetem /ID# 205883	Budapest
Hungary	Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 207992	Sopron
Hungary	Mentahaz Maganorvosi Kozpont /ID# 205882	Szekesfehervar
Ireland	Beaumont Hospital /ID# 206509	Dublin
Ireland	University Hospital Galway /ID# 218035	Galway
Israel	Rambam Health Care Campus /ID# 206362	Haifa
Israel	Shaare Zedek Medical Center /ID# 206365	Jerusalem
Italy	A.O.U. Policlinico S.Orsola-Malpighi /ID# 206351	Bologna	Emilia-Romagna
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 206349	Milan
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 206354	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 206350	Palermo
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216611	Rho	Milano
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 206347	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 206346	Rozzano	Milano
Japan	Tokatsu Tsujinaka Hospital /ID# 214963	Abiko-shi	Chiba
Japan	Tokyo Medical And Dental University, Medical Hospital /ID# 206453	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital /ID# 214405	Chikushino-shi	Fukuoka
Japan	St.Luke's International Hospital /ID# 208076	Chuo-ku	Tokyo
Japan	Fukui Prefectural Hospital /ID# 210449	Fukui-shi	Fukui
Japan	Saiseikai Fukuoka Genaral Hospital /ID# 209482	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 206295	Fukuyama-shi	Hiroshima
Japan	Tokai University Hachioji Hospital /ID# 208903	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 206459	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210710	Higashi-ohmi-shi	Shiga
Japan	Hirosaki National Hospital /ID# 206387	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 206464	Hiroshima-shi	Hiroshima
Japan	Teikyo University Hospital /ID# 209866	Itabashi-ku	Tokyo
Japan	Shimane University School of Medicine /ID# 208905	Izumo-shi	Shimane
Japan	Idzuro Imamura Hospital /ID# 207639	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital /ID# 207935	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 206316	Kanazawa-shi	Ishikawa
Japan	Tsujinaka Hospital Kashiwanoha /ID# 209573	Kashiwa-shi	Chiba
Japan	Saitama Medical Center /ID# 206393	Kawagoe-shi	Saitama
Japan	St. Marianna University School of Medicine Hospital /ID# 209451	Kawasaki-shi	Kanagawa
Japan	Aoyama Clinic /ID# 206452	Kobe-shi	Hyogo
Japan	Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 206646	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 206385	Kurume-shi	Fukuoka
Japan	Kyoto University Hospital /ID# 211809	Kyoto-shi	Kyoto
Japan	Asahikawa Medical University Hospital /ID# 206404	Midorigaokahiga-shi	Hokkaido
Japan	Iwate Medical University Uchimaru Medical Center /ID# 207051	Morioka-shi	Iwate
Japan	Nagoya City University Hospital /ID# 206058	Nagoya shi	Aichi
Japan	Nagoya University Hospital /ID# 206355	Nagoyashi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 218049	Niigata-shi	Niigata
Japan	Saiseikai Niigata Hospital /ID# 209921	Niigata-shi	Niigata
Japan	Hyogo College of Medicine Hospital /ID# 206455	Nishinomiya-shi	Hyogo
Japan	Obihiro kosei Hospital /ID# 210424	Obihiro-shi	Hokkaido
Japan	Ogaki Municipal Hospital /ID# 208227	Ogaki-shi	Gifu
Japan	Ishida Clinic of IBD and Gastroenterology /ID# 210119	Oita-shi	Oita
Japan	Okayama University Hospital /ID# 217925	Okayama-shi	Okayama
Japan	NHO Nagasaki Medical Center /ID# 210822	Omura-shi	Nagasaki
Japan	Japanese Red Cross Osaka Hospital /ID# 209478	Osaka-shi	Osaka
Japan	Kinshukai Infusion Clinic /ID# 207865	Osaka-shi	Osaka
Japan	Kitano Hospital /ID# 210397	Osaka-shi	Osaka
Japan	Osaka City University Hospital /ID# 206457	Osaka-shi	Osaka
Japan	Saga University Hospital /ID# 209270	Saga-shi	Saga
Japan	Tokitokai Tokito clinic /ID# 206313	Saitama-shi	Saitama
Japan	Toho University Medical Center Sakura Hospital /ID# 207705	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 206059	Sapporo-shi	Hokkaido
Japan	Sapporo Higashi Tokushukai Hospital /ID# 208494	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 206314	Sapporo-shi	Hokkaido
Japan	Sapporo Tokushukai Hospital /ID# 209448	Sapporo-shi	Hokkaido
Japan	National Hospital Organization Sendai Medical Center /ID# 209528	Sendai-shi	Miyagi
Japan	Center Hospital of the National Center for Global Health and Medicine /ID# 209532	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital /ID# 206460	Shinjuku-ku	Tokyo
Japan	Tokuyama Central Hospital /ID# 216994	Shunan-shi	Yamaguchi
Japan	NHO Shizuoka Medical Center /ID# 208785	Sunto-gun	Shizuoka
Japan	Shoyukai Fujita Gastroenterological Hospital /ID# 216493	Takatsuki-shi
Japan	Toyohashi Municipal Hospital /ID# 207625	Toyohashi-shi	Aichi
Japan	Toyonaka Municipal Hospital /ID# 217082	Toyonaka-shi	Osaka
Japan	Ieda Hospital /ID# 207479	Toyota-shi	Aichi
Japan	Mie University Hospital /ID# 206803	Tsu-shi	Mie
Japan	Juntendo University Urayasu Hospital /ID# 208784	Urayasu-shi	Chiba
Japan	Yamagata University Hospital /ID# 206465	Yamagata-shi	Yamagata
Japan	Kenseikai Dongo Hospital /ID# 208101	Yamatotakada-shi	Nara
Japan	Yokkaichi Hazu Medical Center /ID# 214348	Yokkaichi-shi	Mie
Japan	Showa University Fujigaoka Hospital /ID# 208224	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 206955	Busan
Korea, Republic of	Pusan National University Hospital /ID# 206956	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 206959	Daegu
Korea, Republic of	Duplicate_CHA Bundang Medical Center /ID# 207432	Seongnam-si, Gyeonggi-do
Korea, Republic of	Kangbuk Samsung Hospital /ID# 206960	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Yonsei University Health System, Severance hospital /ID# 206958	Seoul
Latvia	P. Stradins Clinical Univ Hosp /ID# 206827	Riga
Latvia	Riga East Clinical Univ Hosp /ID# 206828	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 209052	Kaunas
Lithuania	Klaipeda Seamens Hospital /ID# 208791	Klaipeda
Lithuania	Klaipeda University Hospital /ID# 208790	Klaipeda
Lithuania	Vilnius University Hospital /ID# 209051	Vilnius
Malaysia	Duplicate_Uni Malaya MC /ID# 208936	Kuala Lumpur
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 207662	Kuala Lumpur	Selangor
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 208068	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 211326	Leon	Guanajuato
Mexico	Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 208067	Monterrey	Nuevo Leon
Netherlands	Erasmus Medisch Centrum /ID# 205280	Rotterdam
Norway	Akershus Universitetssykehus_MAIN /ID# 205293	Lorenskog	Akershus
Norway	Universitetssykehuset Nord-Norge /ID# 205691	Tromsø	Troms
Poland	Endoskopia Sp. z o.o. /ID# 212964	Sopot	Pomorskie
Poland	Gastromed /Id# 216108	Torun	Kujawsko-pomorskie
Poland	Centrum Medyczne Reuma Park w Warszawie /ID# 212913	Warsaw	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 205874	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215070	Warszawa	Mazowieckie
Poland	NZOZ Vivamed /ID# 216697	Warszawa	Mazowieckie
Portugal	Hospital Garcia de Orta, EPE /ID# 206143	Almada
Portugal	CCA Braga - Hospital de Braga /ID# 206144	Braga
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 205554	Guimaraes	Braga
Portugal	Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 206117	Lisboa
Portugal	Hospital Santo Antonio dos Cap /ID# 206145	Lisbon
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 205556	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 206142	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 205563	Santa Maria Da Feira	Porto
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 209626	San Juan
Russian Federation	Immanuel Kant Baltic Federal University /ID# 208264	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 208256	Kazan	Tatarstan, Respublika
Russian Federation	Olla-Med Clinic /ID# 215335	Moscow
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 211653	Perm	Permskiy Kray
Russian Federation	Republican hospital named after V.A. Baranov /ID# 206507	Petrozavodsk
Russian Federation	Euromedservice /ID# 208265	Pushkin
Russian Federation	LLC Novaya Clinica /ID# 208260	Pyatigorsk
Russian Federation	Medical Company Hepatolog /ID# 208261	Samara	Samarskaya Oblast
Russian Federation	NW State Medical Univ na Mechn /ID# 208258	St. Petersburg	Leningradskaya Oblast
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 211652	Stavropol	Stavropol Skiy Kray
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 206413	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 205258	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 205257	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 205256	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 206410	Kragujevac	Sumadijski Okrug
Serbia	General Hospital Leskovac /ID# 217881	Leskovac
Serbia	University Clinical Center of Nis /ID# 206411	NIS	Nisavski Okrug
Serbia	Clinical Center Vojvodina /ID# 205259	Novi Sad	Vojvodina
Singapore	Gleneagles Medical Centre /ID# 206954	Singapore
Singapore	National University Hospital /ID# 209099	Singapore
Singapore	Tan Tock Seng Hospital /ID# 207663	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 205147	Banska Bystrica
Slovakia	Medak s.r.o. /ID# 205191	Bratislava	Bratislavsky Kraj
Slovakia	B+B MED, s.r.o. /ID# 205213	Kosice
Slovakia	Fakultna nemocnica s poliklini /ID# 211372	Nove Zamky
Slovakia	GASTRO I., s.r.o. /ID# 205148	Presov
South Africa	MD Search /ID# 208084	Boksburg North	Gauteng
South Africa	Kingsbury Hospital /ID# 205281	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 205273	Cape Town	Western Cape
South Africa	Mediclinic Milnerton /ID# 207979	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 208083	Johannesburg	Gauteng
South Africa	Lenasia Clinical Trial Centre /ID# 214359	Johannesburg	Gauteng
South Africa	Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 208082	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 208949	Johannesburg	Gauteng
Spain	Hospital Universitario A Coruna - CHUAC /ID# 206907	A Coruna
Spain	Hospital Clinic de Barcelona /ID# 206906	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 204412	Cordoba
Spain	Hospital Universitario Dr. Negrin /ID# 206905	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario La Paz /ID# 214540	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 204410	Madrid
Spain	Hospital Clinico Universitario de Salamanca /ID# 205013	Salamanca
Spain	Hospital Unversitario Marques de Valdecilla /ID# 216622	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 204411	Santiago de Compostela	A Coruna
Spain	Hospital Universitario y Politecnico La Fe /ID# 206904	Valencia
Switzerland	Universitaetsspital Basel /ID# 211381	Basel
Switzerland	Inselspital, Universitaetsklinik /ID# 211312	Bern
Switzerland	Kantonsspital St. Gallen /ID# 211310	St. Gallen	Sankt Gallen
Switzerland	Universitaetsspital Zuerich /ID# 211308	Zurich
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 207848	Kaohsiung
Taiwan	China Medical University Hosp /ID# 207845	Taichung City	Taichung
Taiwan	National Taiwan University Hospital /ID# 207847	Taipei City	Taipei
Taiwan	Taipei Veterans General Hosp /ID# 207849	Taipei City
Turkey	Gazi University Med. Faculty /ID# 208040	Ankara GAZI
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 207507	Istanbul
Turkey	Umraniye Training and Res Hosp /ID# 208206	Istanbul
Turkey	Erciyes University Medical Fac /ID# 207506	Melikgazi	Kayseri
Turkey	Mersin University Medical /ID# 208039	Mersin
Ukraine	Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical /ID# 206939	Kharkiv	Kharkivska Oblast
Ukraine	PE PMC Acinus, Medical and Diagnostic Center /ID# 217218	Kropyvnytskyi
Ukraine	Kyiv Regional Hospital /ID# 217373	Kyiv	Kyivska Oblast
Ukraine	Medical centre of CONSILIUM MEDICAL LLC /ID# 217447	Kyiv
Ukraine	Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 216300	Vinnytsia
United Kingdom	Basingstoke & North Hampshire /ID# 207985	Basingstoke
United Kingdom	Queen Elizabeth University Hos /ID# 205154	Glasgow
United Kingdom	Huddersfield Royal Infirmary /ID# 217660	Huddersfield
United Kingdom	St. George's Healthcare NHS /ID# 208375	London
United Kingdom	Barts and the London NHS Trust /ID# 205153	Whitechapel
United States	University of New Mexico Department of Internal Medicine /ID# 214397	Albuquerque	New Mexico
United States	Huron Gastroenterology Assoc /ID# 205109	Ann Arbor	Michigan
United States	University of Michigan Health Systems /ID# 206918	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 206718	Arlington	Texas
United States	Digestive Health Partners, P.A /ID# 206842	Asheville	North Carolina
United States	Inquest Clinical Research /ID# 206132	Baytown	Texas
United States	Washington Gastroenterology Associates /ID# 206177	Bellevue	Washington
United States	Advantage Clinical Trials /ID# 206082	Bronx	New York
United States	NY Scientific /ID# 206080	Brooklyn	New York
United States	Texas Digestive Disease Consultants /ID# 209805	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209948	Cedar Park	Texas
United States	Pharmacorp Clinical Trials /ID# 206074	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 206085	Charlotte	North Carolina
United States	Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 207078	Chesterfield	Michigan
United States	Next Innovative Clinical Research - Chicago /ID# 217324	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 206172	Chicago	Illinois
United States	University of Cincinnati /ID# 205633	Cincinnati	Ohio
United States	Gastro Florida /ID# 206174	Clearwater	Florida
United States	Delta Waves, Inc. /ID# 206170	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 206883	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 205638	Columbus	Ohio
United States	The Ohio State University /ID# 205637	Columbus	Ohio
United States	Citrus Valley Gastroenterology /ID# 205627	Covina	California
United States	Tri-State Gastroenterology /ID# 206124	Crestview Hills	Kentucky
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484	Dallas	Texas
United States	Western Connecticut Medical Group /ID# 208290	Danbury	Connecticut
United States	Hometown Urgent Care and Resea /ID# 205630	Dayton	Ohio
United States	Universal Axon Clinical Research /ID# 213462	Doral	Florida
United States	Carle Foundation Hospital /ID# 207397	Effingham	Illinois
United States	AGA Clinical Research Associates, LLC /ID# 206880	Egg Harbor Township	New Jersey
United States	Dayton Gastroenterology, Inc. /ID# 205639	Englewood	Ohio
United States	MediSphere Medical Research Center /ID# 206073	Evansville	Indiana
United States	Duplicate_Plains Clinical Research Center, LLC /ID# 205111	Fargo	North Dakota
United States	Ctr for Gastrointestinal Healt /ID# 208475	Franklin	Virginia
United States	DHAT Research Institute /ID# 206716	Garland	Texas
United States	Gastro One /ID# 206178	Germantown	Tennessee
United States	Gastroenterology Associates, P.A. of Greenville /ID# 206098	Greenville	South Carolina
United States	Gastroenterology Center of CT /ID# 208291	Hamden	Connecticut
United States	Palmetto Research, LLC /ID# 208293	Hialeah	Florida
United States	Houma Digestive Health Special /ID# 206176	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 206717	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 206168	Houston	Texas
United States	GI Specialists of Houston /ID# 206090	Houston	Texas
United States	Vilo Research Group Inc /ID# 212625	Houston	Texas
United States	Care Access Research /ID# 217003	Huntington Beach	California
United States	Indianapolis Gastroenterology /ID# 206381	Indianapolis	Indiana
United States	Nature Coast Clinical Research - Inverness /ID# 206087	Inverness	Florida
United States	University of Iowa Hospitals and Clinics /ID# 206167	Iowa City	Iowa
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 206069	Jackson	Mississippi
United States	University of Mississippi Medical Center /ID# 213116	Jackson	Mississippi
United States	Encore Borland-Groover Clinical Research /Id# 208128	Jacksonville	Florida
United States	East Tennessee Research Institute /ID# 206169	Johnson City	Tennessee
United States	Moore UC San Diego Cancer Center /ID# 204919	La Jolla	California
United States	NYU Langone Long Island Clinical Research Associates /ID# 206079	Lake Success	New York
United States	Las Vegas Medical Research /ID# 206814	Las Vegas	Nevada
United States	United Medical Doctors /ID# 207867	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314	Los Angeles	California
United States	TLC Clinical Research Inc /ID# 216831	Los Angeles	California
United States	Caprock Gastro Research /ID# 215115	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 216940	Macon	Georgia
United States	Cfagi Llc /Id# 207995	Maitland	Florida
United States	Great Lakes Gastroenterology Research LLC /ID# 205631	Mentor	Ohio
United States	Coral Research Clinic /ID# 208292	Miami	Florida
United States	University of Miami /ID# 215445	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital /ID# 206945	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917	Milwaukee	Wisconsin
United States	Facey Medical Foundation /ID# 205301	Mission Hills	California
United States	CB Flock Research Corporation /ID# 206094	Mobile	Alabama
United States	East View Medical Research, LLC /ID# 216933	Mobile	Alabama
United States	Atlantic Digestive Health Inst /ID# 208748	Morristown	New Jersey
United States	United Medical Doctors - Murrieta /ID# 205313	Murrieta	California
United States	Quality Medical Research /ID# 206088	Nashville	Tennessee
United States	Vanderbilt University Medical Center /ID# 210405	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson /ID# 207382	New Brunswick	New Jersey
United States	Advanced Research Institute, Inc /ID# 206077	New Port Richey	Florida
United States	DiGiovanna Institute for Medical Education & Research /ID# 206885	North Massapequa	New York
United States	Advanced Research Institute /ID# 206133	Ogden	Utah
United States	Digestive Disease Specialists /ID# 206076	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 216336	Oklahoma City	Oklahoma
United States	Endoscopic Research, Inc. /ID# 207360	Orlando	Florida
United States	Omega Research Consultants /ID# 206066	Orlando	Florida
United States	InSite Digestive Health Care - Oxnard /ID# 205628	Oxnard	California
United States	Premier Medical Group - GI Division /ID# 206097	Poughkeepsie	New York
United States	Inland Empire Clinical Trials, LLC /ID# 216164	Rialto	California
United States	Infinite Clinical Trials /ID# 215343	Riverdale	Georgia
United States	Gastro Group of Rochester /ID# 206881	Rochester	New York
United States	Mayo Clinic /ID# 205645	Rochester	Minnesota
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 206710	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 205379	San Antonio	Texas
United States	Medical Assoc Research Grp /ID# 205626	San Diego	California
United States	San Diego Clinical Trials /ID# 212122	San Diego	California
United States	Guthrie Medical Group, PC /ID# 206078	Sayre	Pennsylvania
United States	Virginia Mason - Seattle Orthapedics /ID# 206070	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 206064	Shreveport	Louisiana
United States	Revival Research Institute, LLC /ID# 207282	Southfield	Michigan
United States	Richmond University Medical Center /ID# 213185	Staten Island	New York
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030	Sun City	Arizona
United States	Atlanta Gastroenterology Spec /ID# 206173	Suwanee	Georgia
United States	AdventHealth Tampa /ID# 207363	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 206068	Tampa	Florida
United States	University of South Florida /ID# 214495	Tampa	Florida
United States	Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887	Tempe	Arizona
United States	Baylor Scott & White Center for Diagnostic Medicine /ID# 206096	Temple	Texas
United States	Cotton-O'Neil Clinical Res Ctr /ID# 206175	Topeka	Kansas
United States	Center for Digestive Health /ID# 207080	Troy	Michigan
United States	University of Arizona /ID# 208856	Tucson	Arizona
United States	Healthcare Research Consultant /ID# 206706	Tulsa	Oklahoma
United States	Options Health Research, LLC /ID# 206707	Tulsa	Oklahoma
United States	Duplicate_Tyler Research Institue /ID# 206075	Tyler	Texas
United States	The Vancouver Clinic, INC. PS /ID# 204973	Vancouver	Washington
United States	Gastro Health & Nutrition - Victoria /ID# 205378	Victoria	Texas
United States	Western States Clinical Res /ID# 206091	Wheat Ridge	Colorado
United States	Wake Forest Baptist Medical Center /ID# 206067	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  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,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; Clinical remission is defined as an Adapted Mayo score = 2, with SFS = 1 and not higher than Baseline, RBS of 0, and endoscopic subscore = 1.	Week 8
Secondary	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).	Week 8
Secondary	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).	Week 8
Secondary	Percentage of Participants Who Achieved 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 with spontaneous bleeding, ulceration).; The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease.; Clinical response per the Adapted Mayo Score is defined as a decrease in Adapted Mayo score = 2 points and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.	Week 8
Secondary	Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2	The Partial Adapted 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 Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease.; Clinical response per Partial Adapted Mayo Score is defined as a decrease in Partial Adapted Mayo score = 1 point and = 30% from Baseline, plus a decrease in RBS = 1 or an absolute RBS = 1.	Week 2
Secondary	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.	Week 8
Secondary	Percentage of Participants Who Reported No Bowel Urgency at Week 8	Bowel urgency was assessed by participants in a subject diary completed once a day.	Week 8
Secondary	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.	Week 8
Secondary	Percentage of Participants Who Achieved Histologic Improvement at Week 8	Histologic improvement is defined as a decrease from Baseline in Geboes score. 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.	Week 8
Secondary	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) to Week 8
Secondary	Percentage of Participants Who Achieved 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.	Week 8
Secondary	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) to Week 8

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.