A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398148
• Other study ID #: M16-067
• Secondary ID: 2016-004677-40
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 7, 2018
• Est. completion date: May 11, 2023

Study information

• Verified date: July 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1558
• Est. completion date: May 11, 2023
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.

• Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.

• Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.

• Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.

• Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

• Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.

• Participant receiving prohibited medications and treatment.

• Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.

• Participant with currently known complications of UC (e.g., megacolon).

• No known active Coronavirus Disease - 2019 (COVID-19) infection.

Related Conditions & MeSH terms

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

Intervention

Drug:
• risankizumab IV
risankizumab intravenous (IV) infusion
• placebo for risankizumab
placebo for risankizumab
• risankizumab SC
risankizumab subcutaneous (SC) injection

Locations

Country	Name	City	State
Argentina	Cemic /Id# 167782	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Gedyt /ID# 243423	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 167779	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 170898	Rosario	Santa Fe
Argentina	Sanatorio 9 de Julio /ID# 167780	San Miguel de Tucuman	Tucuman
Austria	Medizinische Universitaet Graz /ID# 169053	Graz	Steiermark
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685	Salzburg
Austria	Duplicate_Universitaetsklinikum St.Poelten /ID# 169048	St. Poelten	Niederoesterreich
Austria	Medizinische Universitaet Wien /ID# 169050	Vienna	Wien
Belgium	Imelda Ziekenhuis /ID# 211100	Bonheiden
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252	Brussels	Bruxelles-Capitale
Belgium	CHU UCL Namur - site Godinne /ID# 200254	Godinne	Namur
Belgium	Universitair Ziekenhuis Leuven /ID# 170812	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 200253	Liege
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 200250	Liege
Belgium	AZ-Delta /ID# 200040	Roeselare	West-Vlaanderen
Belgium	UCL Saint-Luc /ID# 200039	Woluwe-Saint-Lambert	Bruxelles-Capitale
Brazil	Upeclin Fmb - Unesp /Id# 157690	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 157671	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 157662	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 163995	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 157680	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Kaspela EOOD /ID# 200797	Plovdiv
Bulgaria	MHAT Hadzhi Dimitar /ID# 207945	Sliven
Bulgaria	Second Multiprofile Hospital f /ID# 200799	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 210797	Sofia
Bulgaria	UMHAT Tsaritsa Joanna - ISUL /ID# 209977	Sofia
Canada	University of Calgary /ID# 169111	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 169767	Edmonton	Alberta
Canada	Covenant Health /ID# 169114	Edmonton	Alberta
Canada	Hotel Dieu de Levis /ID# 214378	Lévis	Quebec
Canada	London Health Sciences Center /ID# 169103	London	Ontario
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108	Montreal	Quebec
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 169104	Montreal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 169102	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 169113	North Bay	Ontario
Canada	Toronto Digestive Disease Asso /ID# 169106	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 169109	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 210761	Concepción
Chile	Complejo Asistencial Dr. Sotero del Rio /ID# 169385	Santiago	Region Metropolitana Santiago
Chile	Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125	Santiago	Region Metropolitana Santiago
Chile	Hospital Las Higueras /ID# 167093	Talcahuano
Chile	Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151	Victoria	Araucania
China	Beijing Friendship Hospital /ID# 211066	Beijing	Beijing
China	The First Hospital of Jilin University /ID# 212278	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University /ID# 211198	Changsha
China	West China Hospital, Sichuan University /ID# 211276	Chengdu	Sichuan
China	The Sixth Affiliated Hosp Sun /ID# 211231	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University /ID# 211228	Hefei	Anhui
China	Huai'an First People's Hospital /ID# 239196	Huaian	Jiangsu
China	The First Affiliated Hospital of Nanchang University /ID# 212183	Nanchang	Jiangxi
China	Jiangsu Province Hospital /ID# 211232	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital /ID# 227439	Nanjing	Jiangsu
China	Shanghai East Hospital /ID# 218791	Pudong New District	Shanghai
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962	Shanghai	Shanghai
China	Shanghai General Hospital /ID# 226190	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 211646	Shenyang
China	The Second Hospital of Hebei Medical University /ID# 213018	Shijiazhuang	Hebei
China	Renmin Hospital of Wuhan University /ID# 212868	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of HUST /ID# 211072	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071	Wuhan
China	Wuxi People's Hospital /ID# 218798	Wuxi	Jiangsu
China	Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504	Xi'an	Shaanxi
China	Xijing Hospital /ID# 211639	Xi'an	Shaanxi
China	General Hospital of Ningxia Medical University /ID# 213911	Yinchuan City	Ningxia
Colombia	Hospital Universitario San Vic /ID# 171490	Medellin
Colombia	Oncomédica SAS /ID# 206937	Monteria	Cordoba
Croatia	Klinicki bolnicki centar Osijek /ID# 157472	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 157473	Split	Splitsko-dalmatinska Zupanija
Croatia	Clinical Hospital Dubrava /ID# 157475	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 157471	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 201917	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne /ID# 239157	Brno
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 225226	Ceske Budejovice
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 163395	Hradec Kralove
Czechia	Fakultni nemocnice Ostrava /ID# 225567	Ostrava
Denmark	Bispebjerg and Frederiksberg Hospital /ID# 208945	Copenhagen NV	Hovedstaden
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266	Hvidovre	Hovedstaden
Denmark	Odense University Hospital /ID# 205602	Odense C	Syddanmark
Denmark	Sjællands Universitetshospital /ID# 200033	Roskilde	Sjælland
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794	Alexandria
Egypt	Air Force Specialized Hospital /ID# 170986	Cairo
Egypt	National Liver Institute /ID# 171040	Menoufiya
France	CHU Amiens-Picardie Site Sud /ID# 171576	Amiens CEDEX 1	Somme
France	Hopital Beaujon /ID# 200092	Clichy	Ile-de-France
France	APHM - Hopital Nord /ID# 225825	Marseille	Bouches-du-Rhone
France	CHU Montpellier - Hôpital Saint Eloi /ID# 223779	Montpellier Cedex 5	Herault
France	Clinique Jules Verne /ID# 240976	Nantes
France	Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249860	Neuilly Sur Seine	Ile-de-France
France	Chu de Nice-Hopital L'Archet Ii /Id# 171577	Nice	Alpes-Maritimes
France	CHU Bordeaux - Hopital Haut Leveque /ID# 171579	Pessac	Gironde
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 171580	St. Priest En Jarez	Loire
France	CHRU Nancy - Hopitaux de Brabois /ID# 200095	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510	Berlin
Germany	DRK Kliniken Berlin Westend /ID# 166153	Berlin
Germany	Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145	Berlin
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361	Berlin
Germany	Stadtisches Klinikum Braunschweig /ID# 163687	Braunschweig
Germany	Universitaetsklinikum Erlangen /ID# 159354	Erlangen	Bayern
Germany	Agaplesion Markus Krankenhaus /ID# 159356	Frankfurt am Main
Germany	Universitaetsklinikum Freiburg /ID# 162034	Freiburg	Baden-Wuerttemberg
Germany	Praxiszentrum fuer Gastroenterologie /ID# 219069	Grevenbroich	Nordrhein-Westfalen
Germany	Praxis fuer Gastroenterologie /ID# 166152	Heidelberg	Baden-Wuerttemberg
Germany	Gastroenterologie Opernstrasse /ID# 163683	Kassel
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Koeln /ID# 164991	Köln	Nordrhein-Westfalen
Germany	EUGASTRO GmbH /ID# 219070	Leipzig
Germany	Klinikum Lueneburg /ID# 163685	Lueneburg
Germany	Universitatsklinikum Mannheim /ID# 162035	Mannheim	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033	Minden
Germany	LMU Klinikum Campus Grosshadern /ID# 210481	München
Germany	Universitaetsklinikum Regensburg /ID# 163686	Regensburg
Germany	Universitaetsklinikum Ulm /ID# 164992	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480	Athens
Greece	General Hospital of Athens Ippokratio /ID# 229189	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 206440	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 165216	Heraklion	Kriti
Greece	Tzaneio general hospital of Piraeus /ID# 206439	Piraeus	Attiki
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218	Pireaus
Greece	Theageneio Anticancer Hospital /ID# 165217	Thessaloniki
Israel	Soroka University Medical Center /ID# 171100	Be'er Sheva	HaDarom
Israel	Rambam Health Care Campus /ID# 171103	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 171099	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 163544	Jerusalem
Israel	Rabin Medical Center /ID# 167403	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 211278	Ramat Gan	Tel-Aviv
Italy	Ospedale Sant Orsola Malpighi /ID# 155611	Bologna	Emilia-Romagna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 164036	Catania
Italy	University of Catanzaro /ID# 200125	Catanzaro	Calabria
Italy	Ospedale Policlinico San Martino /ID# 164031	Genoa	Genova
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607	Milano
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 170947	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 201819	Modena
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041	Negrar	Verona
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 155612	Rome	Lazio
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158018	Rome	Roma
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226	Rome	Lazio
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163992	Rome	Lazio
Italy	UOC Medicina Interna e Gastroe /ID# 155608	Rome
Italy	Istituto Clinico Humanitas /ID# 155610	Rozzano	Milano
Japan	Tokatsu Tsujinaka Hospital /ID# 164438	Abiko-shi	Chiba
Japan	Asahikawa Medical University Hospital /ID# 164433	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 164258	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 209632	Chiba-shi	Chiba
Japan	Fukuoka University Chikushi Hospital /ID# 209055	Chikushino-shi	Fukuoka
Japan	St.Luke's International Hospital /ID# 225822	Chuo-ku	Tokyo
Japan	Fukuoka University Hospital /ID# 226189	Fukuoka-shi	Fukuoka
Japan	Saiseikai Fukuoka Genaral Hospital /ID# 225639	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 164439	Fukuyama-shi	Hiroshima
Japan	Gifu University Hospital /ID# 208081	Gifu-shi	Gifu
Japan	Tokai University Hachioji Hospital /ID# 226899	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 226727	Hamamatsu-shi	Shizuoka
Japan	Matsuda Hospital /ID# 226616	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Hirosaki General Medical Center /ID# 164252	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 164426	Hiroshima-shi	Hiroshima
Japan	Tokai University Hospital /ID# 209204	Isehara-shi	Kanagawa
Japan	Teikyo University Hospital /ID# 225588	Itabashi-ku	Tokyo
Japan	Sameshima Hospital /ID# 211181	Kagoshima-shi	Kagoshima
Japan	Gokeikai Ofuna Chuo Hospital /ID# 169300	Kamakura-shi	Kanagawa
Japan	Kanazawa University Hospital /ID# 169224	Kanazawa-shi	Ishikawa
Japan	Nara Medical University Hospital /ID# 169225	Kashihara-shi	Nara
Japan	Tsujinaka Hospital Kashiwanoha /ID# 208964	Kashiwa-shi	Chiba
Japan	St. Marianna University Hospital /ID# 226728	Kawasaki-shi	Kanagawa
Japan	Aoyama Clinic /ID# 164425	Kobe-shi	Hyogo
Japan	Kurume University Hospital /ID# 164427	Kurume-shi	Fukuoka
Japan	Kitasato University Kitasato Institute Hospital /ID# 164256	Minato-ku	Tokyo
Japan	The Jikei University Hospital /ID# 164434	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 164259	Mitaka-shi	Tokyo
Japan	Aichi Medical University Hospital /ID# 164332	Nagakute-shi	Aichi
Japan	Nagasaki University Hospital /ID# 202674	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 164331	Nagoya shi	Aichi
Japan	Daido Clinic /ID# 211479	Nagoya-shi	Aichi
Japan	Nagoya University Hospital /ID# 164271	Nagoya-shi	Aichi
Japan	Hyogo Medical University Hospital /ID# 164424	Nishinomiya-shi	Hyogo
Japan	Ogaki Municipal Hospital /ID# 226010	Ogaki-shi	Gifu
Japan	Kinshukai Infusion Clinic /ID# 226747	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 164440	Otsu-shi	Shiga
Japan	Saga University Hospital /ID# 209396	Saga-shi	Saga
Japan	Kitasato University Hospital /ID# 169226	Sagamihara-shi	Kanagawa
Japan	Tokitokai Tokito clinic /ID# 164253	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 164254	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251	Sapporo-shi	Hokkaido
Japan	Sapporo Higashi Tokushukai Hospital /ID# 208488	Sapporo-shi	Hokkaido
Japan	Sapporo IBD Clinic /ID# 225923	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 164432	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 164430	Sendai-shi	Miyagi
Japan	NTT Medical Center Tokyo /ID# 225587	Shinagawa-ku	Tokyo
Japan	Keio University Hospital /ID# 203629	Shinjuku-ku	Tokyo
Japan	Tokuyama Central Hospital /ID# 226011	Shunan-shi	Yamaguchi
Japan	NHO Shizuoka Medical Center /ID# 164435	Sunto-gun	Shizuoka
Japan	National Hospital Organization Takasaki General Medical Center /ID# 164437	Takasaki-shi	Gunma
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 226035	Takatsuki-shi	Osaka
Japan	Fujita Health University Hospital /ID# 164261	Toyoake-shi	Aichi
Japan	Mie University Hospital /ID# 203633	Tsu-shi	Mie
Japan	Japanese Red Cross Wakayama Medical Center /ID# 171195	Wakayama-shi	Wakayama
Japan	Wakayama Medical University Hospital /ID# 169487	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 171474	Yamagata-shi	Yamagata
Japan	Yokkaichi Hazu Medical Center /ID# 164441	Yokkaichi-shi	Mie
Japan	Colo-proctology Center Matsushima Clinic /ID# 225914	Yokohama-shi	Kanagawa
Japan	Showa University Fujigaoka Hospital /ID# 209555	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 158705	Busan
Korea, Republic of	Inje University Haeundae Hospital /ID# 203028	Busan
Korea, Republic of	Pusan National University Hospital /ID# 158711	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 158703	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378	Daejeon
Korea, Republic of	Hanyang University Gurihospital /ID# 158702	Guri	Gyeonggido
Korea, Republic of	CHA University Bundang Medical Center /ID# 158710	Seongnam si	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 158707	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 158704	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 158701	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706	Suwon	Gyeonggido
Latvia	Pauls Stradins Clinical University Hospital /ID# 163803	Riga
Latvia	VCA Polyclinic Aura /ID# 163802	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 170614	Vilnius
Malaysia	Universiti Sains Malaysia /ID# 221971	Kelantan
Mexico	JM Research SC /ID# 203593	Cuernavaca	Morelos
Mexico	Health Pharma Professional Research S.A de C.V /ID# 203597	Del. Benito Juárez
Mexico	Unidad de Atencion Medica e Investigacion en Salud /ID# 203595	Merida	Yucatan
Netherlands	Academisch Medisch Centrum /ID# 157959	Amsterdam
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 163767	Tilburg
New Zealand	Christchurch Hospital /ID# 205342	Christchurch	Canterbury
New Zealand	Waikato Hospital /ID# 212789	Hamilton	Waikato
New Zealand	Hutt Hospital /ID# 212786	Lower Hutt
New Zealand	Wellington Regional Hospital /ID# 205343	Newtown	Wellington
New Zealand	Dunedin Hospital /ID# 212790	Otago
New Zealand	Tauranga Hospital /ID# 212792	Tauranga South	Bay Of Plenty
Poland	Vitamed Galaj i Cichomski Sp.j. /ID# 213283	Bydgoszcz	Kujawsko-pomorskie
Poland	NZOZ All-Medicus /ID# 170596	Katowice	Slaskie
Poland	Centrum Medyczne Plejady /ID# 170633	Krakow	Malopolskie
Poland	Endoskopia Sp. z o.o. /ID# 170598	Sopot	Pomorskie
Poland	Gastromed Sp. z o.o /ID# 230978	Torun	Kujawsko-pomorskie
Poland	H-T. Centrum Medyczne - Endoterapia /ID# 230979	Tychy	Slaskie
Poland	WIP Warsaw IBD Point Profesor Kierkus /ID# 216102	Warsaw	Mazowieckie
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170601	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 170597	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 170600	Warszawa	Mazowieckie
Poland	NZOZ Vivamed Jadwiga Miecz /ID# 216307	Warszawa	Mazowieckie
Poland	Vistamed /ID# 210105	Wroclaw	Dolnoslaskie
Portugal	Hospital Garcia de Orta, EPE /ID# 165583	Almada
Portugal	Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054	Coimbra
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580	Guimaraes	Braga
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582	Lisboa
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551	Portimão	Faro
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 166052	Santa Maria Da Feira	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 166053	Viseu
Puerto Rico	Ponce Medical School Foundation /ID# 221244	Ponce
Puerto Rico	San Jorge Children Hospital /ID# 166954	San Juan
Puerto Rico	VA Caribbean Healthcare System /ID# 221245	San Juan
Romania	Fundeni Clinical Institute /ID# 171264	Bucharest
Romania	Fundeni Clinical Institute /ID# 224168	Bucharest
Romania	Sana Monitoring /Id# 224166	Bucharest
Romania	Clinica GASTRO MED SRL /ID# 224169	Cluj-Napoca	Cluj
Romania	Cabinet Particular Policlinic Algomed /ID# 171266	Timi?oara
Romania	Duplicate_Centrul Medical Tuculanu SRL /ID# 171268	Timisoara
Russian Federation	Interdisctrict Multidisciplinary Hospital /ID# 203335	Anzorey	Kabardino-Balkarskaya Respublika
Russian Federation	Clinic of New Technologies of Medicine /ID# 203369	Dzerzhinskiy
Russian Federation	Immanuel Kant Baltic Federal University /ID# 204888	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kuzbass Regional Clinical Hospital /ID# 165750	Kemerovo	Kemerovskaya Oblast
Russian Federation	Arsvita Clinic /ID# 208946	Korolev	Moskovskaya Oblast
Russian Federation	Central Clinical Hospital RZHD Medicine /ID# 204917	Moscow
Russian Federation	First Moscow State Medical University n.a I.M. Sechenov /ID# 204978	Moscow
Russian Federation	National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512	Moscow
Russian Federation	GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973	Nalchik	Kabardino-Balkarskaya Respublika
Russian Federation	Novosibirski Gastrocenter /ID# 229855	Novosibirsk
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457	Perm	Permskiy Kray
Russian Federation	Euromedservice /ID# 204892	Pushkin
Russian Federation	Uninova Medical Center /ID# 229216	Saint Petersburg	Leningradskaya Oblast
Russian Federation	City Clinical Hospital #40 /ID# 203370	Sestroretsk	Sankt-Peterburg
Russian Federation	International Medical Center SOGAZ /ID# 206727	St. Petersburg
Russian Federation	Regional Clinical Hospital #1 /ID# 165754	Tyumen	Tyumenskaya Oblast
Russian Federation	Ulyanovsk Regional Clinical Hospital /ID# 203368	Ulyanovsk
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 202059	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 200151	Belgrade	Beograd
Serbia	Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926	Belgrade
Serbia	University Clinical Center Serbia /ID# 200152	Belgrade	Beograd
Serbia	General Hospital Leskovac /ID# 207226	Leskovac
Serbia	Clinical Center Vojvodina /ID# 156910	Novi Sad	Vojvodina
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 205738	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 206602	Nitra
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099	Nove Zamky
Slovakia	GASTRO I., s.r.o. /ID# 164346	Presov
Slovenia	Univ Medical Ctr Ljubljana /ID# 210627	Ljubljana
South Africa	Farmovs (Pty) Ltd /Id# 207537	Bloemfontein	Free State
South Africa	Allergy & Immunology (AIU) /ID# 171441	Cape Town	Western Cape
South Africa	Dr JP Wright /ID# 171138	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 171137	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 229905	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 239824	Johannesburg	Gauteng
Spain	Hospital Clinic de Barcelona /ID# 159439	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 167058	Cordoba
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440	Ferrol	A Coruna
Spain	Hospital de Cabuenes /ID# 170748	Gijon	Asturias
Spain	Hospital Universitario La Paz /ID# 159459	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443	Majadahonda	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 216182	Pontevedra
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461	Sabadell	Barcelona
Spain	Hospital Universitario de Salamanca /ID# 159446	Salamanca
Spain	Hospital Universitario Virgen Macarena /ID# 159968	Sevilla
Spain	Hospital Alvaro Cunqueiro CHUVI /ID# 167360	Vigo	Pontevedra
Spain	Hospital Universitario Miguel Servet /ID# 159445	Zaragoza
Sweden	Alingsas lasarett /ID# 202074	Alingsas	Vastra Gotalands Lan
Sweden	Sahlgrenska University Hospital Molndal /ID# 202843	Molndal	Vastra Gotalands Lan
Sweden	Danderyds sjukhus AB /ID# 202035	Stockholm
Switzerland	Inselspital, Universitätsspital Bern /ID# 202911	Bern
Switzerland	Universitatsspital Zurich /ID# 202910	Zurich	Zuerich
Taiwan	China Medical University Hospital /ID# 160189	Taichung
Taiwan	Chung Shan Medical University Hospital /ID# 163651	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 163649	Taichung
Taiwan	Taipei Veterans General Hosp /ID# 163650	Taipei
Taiwan	National Taiwan University Hospital /ID# 162187	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 222877	Taoyuan City
Turkey	Ankara Univ Medical Faculty /ID# 167210	Ankara
Turkey	Inonu Universitesi Turgut Ozal /ID# 203981	Battalgazi/malatya
Turkey	Uludag University Medical Faculty /ID# 204182	Bursa
Turkey	Firat University Medical Facul /ID# 171292	Elazig
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293	Istanbul
Turkey	Acibadem Kozyatagi Hospital /ID# 213276	Kadikoy	Istanbul
Turkey	Erciyes University Medical Fac /ID# 171291	Melikgazi	Kayseri
Turkey	Sisli Etfal Train & Res Hosp /ID# 171409	Sisli
Ukraine	CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367	Ivano-frankivsk
Ukraine	Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350	Kherson
Ukraine	CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343	Kyiv
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 224348	Kyiv
Ukraine	Medical Center "OK!Clinic+" /ID# 205482	Kyiv
United Kingdom	Barnsley Hospital NHS Foundation Trust /ID# 202770	Barnsley
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 158040	Cambridge
United Kingdom	NHS Lothian /ID# 208802	Edinburgh
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust /ID# 157587	Exeter	Devon
United Kingdom	Liverpool University Hospitals NHS Foundation Trust /ID# 203858	Liverpool
United Kingdom	Barts Health NHS Trust /ID# 157590	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 158766	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041	Newcastle upon Tyne
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 210813	Southampton	Hampshire
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 208378	Tooting
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524	Ann Arbor	Michigan
United States	Inquest Clinical Research /ID# 165685	Baytown	Texas
United States	Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255	Boston	Massachusetts
United States	Texas Digestive Disease Consultants /ID# 209798	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209950	Cedar Park	Texas
United States	Atrium Health Carolinas Medical Center /ID# 158512	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 160327	Chesterfield	Michigan
United States	The University of Chicago Medical Center /ID# 160521	Chicago	Illinois
United States	South Lake Pain Institute, Inc /ID# 162878	Clermont	Florida
United States	Cleveland Clinic Main Campus /ID# 209232	Cleveland	Ohio
United States	Peak Gastroenterology Associates, PC /ID# 165841	Colorado Springs	Colorado
United States	Optimed Research, Ltd. /ID# 167113	Columbus	Ohio
United States	The Ohio State University /ID# 164714	Columbus	Ohio
United States	Gastro One /ID# 160418	Cordova	Tennessee
United States	Southern California Res. Ctr. /ID# 169660	Coronado	California
United States	Plains Clinical Research Center, LLC /ID# 169732	Fargo	North Dakota
United States	DHAT Research Institute /ID# 158226	Garland	Texas
United States	Carolina Research /ID# 201090	Greenville	North Carolina
United States	Gastroenterology Associates, P.A. of Greenville /ID# 160472	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 160311	Hamden	Connecticut
United States	Penn State Milton S. Hershey Medical Center /ID# 223563	Hershey	Pennsylvania
United States	Houma Digestive Health Special /ID# 158317	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 158221	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201222	Houston	Texas
United States	CliniCore International, LLC /ID# 158218	Houston	Texas
United States	Precision Research Institute, LLC /ID# 201351	Houston	Texas
United States	Vilo Research Group Inc /ID# 207656	Houston	Texas
United States	Indiana University /ID# 167252	Indianapolis	Indiana
United States	Hoag Memorial Hosp Presbyterian /ID# 218348	Irvine	California
United States	East Tennessee Research Institute /ID# 168747	Johnson City	Tennessee
United States	Univ Kansas Med Ctr /ID# 226602	Kansas City	Kansas
United States	UC San Diego Health System /ID# 160452	La Jolla	California
United States	Rocky Mountain Pediatric Gastroenterology /ID# 207174	Lone Tree	Colorado
United States	United Medical Doctors /ID# 158528	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931	Los Angeles	California
United States	Robley Rex VA Medical Center /ID# 218648	Louisville	Kentucky
United States	Caprock Gastro Research, LLC /ID# 215432	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 160523	Macon	Georgia
United States	Ctr for Advanced Gastroenterol /ID# 202811	Maitland	Florida
United States	Great Lakes Gastroenterology Research, LLC /ID# 201777	Mentor	Ohio
United States	Coral Research Clinic /ID# 158584	Miami	Florida
United States	South Florida Research Ph I-IV, Inc. /ID# 161848	Miami	Florida
United States	University of Miami /ID# 160471	Miami	Florida
United States	Gastroenterology Group Naples /ID# 165212	Naples	Florida
United States	Vanderbilt University Medical Center /ID# 160580	Nashville	Tennessee
United States	Yale Univ Digestive Diseases /ID# 213179	New Haven	Connecticut
United States	Delricht Research /ID# 206815	New Orleans	Louisiana
United States	Nola Research Works, LLC /ID# 161368	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 161938	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 161934	New York	New York
United States	Lenox Hill Hospital /ID# 168470	New York	New York
United States	Manhattan Clinical Research, LLC /ID# 211805	New York	New York
United States	Weill Cornell Medicine /ID# 165887	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 171129	North Massapequa	New York
United States	DM Clinical Research/Southwest /ID# 165012	Oak Lawn	Illinois
United States	Advanced Research Institute /ID# 160480	Ogden	Utah
United States	Digestive Disease Specialists /ID# 170779	Oklahoma City	Oklahoma
United States	Quality Clinical Research Inc. /ID# 167313	Omaha	Nebraska
United States	Advent Health /ID# 160433	Orlando	Florida
United States	Endoscopic Research, Inc. /ID# 206711	Orlando	Florida
United States	Omega Research Group /ID# 203059	Orlando	Florida
United States	University of Pennsylvania /ID# 166266	Philadelphia	Pennsylvania
United States	Gastroenterology Consultants of Southwest Virginia /ID# 218143	Roanoke	Virginia
United States	Mayo Clinic - Rochester /ID# 200458	Rochester	Minnesota
United States	University of Rochester Medical Center /ID# 161664	Rochester	New York
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 161376	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 168776	San Antonio	Texas
United States	UCSF Center for Colitis and Crohn's Disease /ID# 201210	San Francisco	California
United States	Virginia Mason Medical Center /ID# 160466	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 201204	Shreveport	Louisiana
United States	Atlanta Gastroenterology Spec /ID# 161372	Suwanee	Georgia
United States	Lenus Research & Medical Group /ID# 169730	Sweetwater	Florida
United States	ProMedica Physicians Digestive Healthcare /ID# 215623	Sylvania	Ohio
United States	AdventHealth Tampa /ID# 170503	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 201783	Tampa	Florida
United States	Baylor Scott & White Center for Diagnostic Medicine /ID# 204130	Temple	Texas
United States	Cotton-O'Neil Clinical Res Ctr /ID# 160412	Topeka	Kansas
United States	Adult Gastroenterology Associates - Gen 1 Research /ID# 208867	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 166800	Tyler	Texas
United States	Gastro Health & Nutrition - Victoria /ID# 164321	Victoria	Texas
United States	Cedars-Sinai Medical Center-West Hollywood /ID# 163851	West Hollywood	California
United States	Digestive Disease Associates, LTD /ID# 232407	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Egypt,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sub-Study 1 and Sub-Study 2: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score	Clinical remission per adapted Mayo Score.	Week 12
Secondary	Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement per endoscopy subscore.	Week 12
Secondary	Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline	Clinical remission per Full Mayo Score.	Week 12
Secondary	Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score	Clinical response per adapted Mayo Score.	Week 12
Secondary	Sub-Study 1: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score	Clinical response per Partial Adapted Mayo Score (without endoscopy).	Week 4
Secondary	Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission per endoscopy subscore.	Week 12
Secondary	Sub-Study 1: Percentage of Participants with Hospitalization	Participants with an event that results in admission to the hospital.	Through Week 12
Secondary	Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR)	Mucosal healing defined as endoscopic and histologic remission.	Week 12
Secondary	Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)	The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.	Baseline Through Week 12
Secondary	Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)	The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.	Baseline Through Week 12
Secondary	Sub-Study 1: Change in Short Form-36 (SF-36)	The SF-36 is an indicator of overall health status.	Baseline Through Week 12
Secondary	Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.	Baseline Through Week 12
Secondary	Sub-Study 1: Percentage of Participants Undergoing Ulcerative Colitis (UC)-related Surgeries	Participants who underwent surgery related to UC.	Through Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score	Clinical response per adapted Mayo Score.	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement per endoscopy subscore.	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement (HEMI)	Endoscopic subscore of 0 or 1 without evidence of friability and Geboes score = 3.1) at Week 12	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission per endoscopy subscore.	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo Score at Week 4	Clinical response per Partial Adapted Mayo Score (without endoscopy).	Week 4
Secondary	Sub-Study 2: Percentage of Participants Achieving No Bowel Urgency	Percentage of participants who reported no bowel urgency.	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving No Abdominal Pain	Percentage of participants who reported no abdominal pain.	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR): Endoscopy Subscore of 0 and Geboes Score < 2.0) at Week 12	Mucosal healing defined as endoscopic and histologic remission.	Week 12
Secondary	Sub-Study 2: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.	Baseline to Week 12
Secondary	Sub-Study 2: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) total score	The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.	Baseline to Week 12
Secondary	Sub-Study 2: Occurrence of UC-related Hospitalizations	Participants with an UC-related event that results in admission to the hospital.	Baseline Through Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving No Nocturnal Bowel Movements	Percentage of participants who reported no nocturnal bowel movements.	Week 12
Secondary	Sub-Study 2: Percentage of Participants Achieving No Tenesmus	Percentage of participants who reported no tenesmus.	Week 12
Secondary	Sub-Study 2: Change in Number of Fecal Incontinence Episodes per Week	Change in number of fecal incontinence episodes per week.	Baseline to Week 12
Secondary	Sub-Study 2: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms	Change in number of days per week with sleep interrupted due to UC symptoms.	Baseline to Week 12

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