A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Ulcerative Colitis (UC) Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03398135
• Other study ID #: M16-066
• Secondary ID: 2016-004676-2220
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 28, 2018
• Est. completion date: September 25, 2028

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1242
• Est. completion date: September 25, 2028
• Est. primary completion date: September 25, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.

Exclusion Criteria:

• Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
• Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
• Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.

Related Conditions & MeSH terms

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

Intervention

Drug:
• risankizumab
subcutaneous (SC) injection
• placebo for risankizumab
subcutaneous (SC) injection

Locations

Country	Name	City	State
Argentina	Cemic /Id# 167805	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Gedyt /ID# 243424	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 167802	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 170896	Rosario	Santa Fe
Argentina	Sanatorio 9 de Julio /ID# 167803	San Miguel de Tucuman	Tucuman
Austria	Medizinische Universitaet Graz /ID# 169052	Graz	Steiermark
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 216043	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200686	Salzburg
Austria	Duplicate_Universitaetsklinikum St.Poelten /ID# 169049	St. Poelten	Niederoesterreich
Austria	Medizinische Universitaet Wien /ID# 169051	Vienna	Wien
Belgium	Imelda Ziekenhuis /ID# 211101	Bonheiden
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200256	Brussels	Bruxelles-Capitale
Belgium	CHU UCL Namur - site Godinne /ID# 200259	Godinne	Namur
Belgium	Universitair Ziekenhuis Leuven /ID# 170829	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 200257	Liege
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 200255	Liege
Belgium	AZ-Delta /ID# 200258	Roeselare	West-Vlaanderen
Belgium	UCL Saint-Luc /ID# 200260	Woluwe-Saint-Lambert	Bruxelles-Capitale
Brazil	Upeclin Fmb - Unesp /Id# 157691	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 157677	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157683	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 157670	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157668	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 163993	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 157686	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Kaspela EOOD /ID# 200795	Plovdiv
Bulgaria	MHAT Hadzhi Dimitar /ID# 207947	Sliven
Bulgaria	Second MHAT Sofia /ID# 200794	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 210798	Sofia
Bulgaria	UMHAT Tsaritsa Joanna - ISUL /ID# 209978	Sofia
Canada	University of Calgary /ID# 169125	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 169770	Edmonton	Alberta
Canada	Covenant Health /ID# 169128	Edmonton	Alberta
Canada	Hotel Dieu de Levis /ID# 214379	Lévis	Quebec
Canada	London Health Sciences Center- University Hospital /ID# 169117	London	Ontario
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122	Montreal	Quebec
Canada	Montreal General Hospital- McGill University Health Center /ID# 169118	Montreal
Canada	Fraser Clinical Trials Inc /ID# 169116	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 169127	North Bay	Ontario
Canada	Toronto Digestive Disease Associates, Inc. /ID# 169120	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 169123	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 210762	Concepción
Chile	Complejo Asistencial Dr. Sotero del Rio /ID# 169386	Santiago	Region Metropolitana Santiago
Chile	Hospital Las Higueras /ID# 167094	Talcahuano
Chile	Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213152	Victoria	Araucania
China	Beijing Friendship Hospital /ID# 211061	Beijing	Beijing
China	The First Hospital of Jilin University /ID# 212277	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University /ID# 211196	Changsha
China	West China Hospital, Sichuan University /ID# 211275	Chengdu	Sichuan
China	The Sixth Affiliated Hosp Sun /ID# 211229	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211062	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211024	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University /ID# 211227	Hefei	Anhui
China	Huai'an First People's Hospital /ID# 239197	Huaian	Jiangsu
China	The First Affiliated Hospital of Nanchang University /ID# 212182	Nanchang	Jiangxi
China	Jiangsu Province Hospital /ID# 211234	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital /ID# 227438	Nanjing	Jiangsu
China	Shanghai East Hospital /ID# 218796	Pudong New District	Shanghai
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211230	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210960	Shanghai	Shanghai
China	Shanghai General Hospital /ID# 226652	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 211643	Shenyang
China	The Second Hospital of Hebei Medical University /ID# 213019	Shijiazhuang	Hebei
China	Renmin Hospital of Wuhan University /ID# 212867	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of HUST /ID# 211069	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211070	Wuhan	Hubei
China	Wuxi People's Hospital /ID# 218797	Wuxi	Jiangsu
China	Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215505	Xi'an	Shaanxi
China	Xijing Hospital /ID# 210708	Xi'an	Shaanxi
China	General Hospital of Ningxia Medical University /ID# 213912	Yinchuan City	Ningxia
Colombia	Hospital Universitario San Vic /ID# 171488	Medellin
Colombia	Oncomedica SAS /ID# 207041	Monteria	Cordoba
Croatia	Klinicki bolnicki centar Osijek /ID# 157595	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 157596	Split	Splitsko-dalmatinska Zupanija
Croatia	Clinical Hospital Dubrava /ID# 157598	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 157594	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 201915	Zagreb	Grad Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne /ID# 239158	Brno
Czechia	SurGal Clinic s.r.o. /ID# 252300	Brno
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 225228	Ceske Budejovice
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 163389	Hradec Kralove
Czechia	Fakultni nemocnice Ostrava /ID# 225568	Ostrava
Denmark	Bispebjerg and Frederiksberg Hospital /ID# 208953	Copenhagen NV	Hovedstaden
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 205093	Hvidovre	Hovedstaden
Denmark	Odense Universitets Hospital /ID# 209502	Odense C	Syddanmark
Denmark	Sjællands Universitetshospital /ID# 200073	Roskilde	Sjælland
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 201824	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226795	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226796	Alexandria
Egypt	Air Force Specialized Hospital /ID# 170984	Cairo
Egypt	National Liver Institute /ID# 171042	Menoufiya
France	CHU Amiens-Picardie Site Sud /ID# 207880	Amiens CEDEX 1	Somme
France	Hopital Beaujon /ID# 207876	Clichy	Ile-de-France
France	APHM - Hopital Nord /ID# 225826	Marseille	Bouches-du-Rhone
France	CHU Montpellier - Hôpital Saint Eloi /ID# 223781	Montpellier Cedex 5	Herault
France	Clinique Jules Verne /ID# 240977	Nantes
France	Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249861	Neuilly Sur Seine	Ile-de-France
France	Chu de Nice-Hopital L'Archet Ii /Id# 207881	Nice	Alpes-Maritimes
France	CHU Bordeaux - Hopital Haut Leveque /ID# 207883	Pessac	Gironde
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 207882	St. Priest En Jarez	Loire
France	CHRU Nancy - Hopitaux de Brabois /ID# 207877	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210508	Berlin
Germany	DRK Kliniken Berlin Westend /ID# 166155	Berlin
Germany	Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219146	Berlin
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159380	Berlin
Germany	Stadtisches Klinikum Braunschweig /ID# 163694	Braunschweig
Germany	Universitaetsklinikum Erlangen /ID# 159373	Erlangen	Bayern
Germany	Agaplesion Markus Krankenhaus /ID# 159375	Frankfurt am Main
Germany	Universitaetsklinikum Freiburg /ID# 162038	Freiburg	Baden-Wuerttemberg
Germany	Praxiszentrum fuer Gastroenterologie /ID# 219072	Grevenbroich	Nordrhein-Westfalen
Germany	Praxis fuer Gastroenterologie /ID# 166154	Heidelberg	Baden-Wuerttemberg
Germany	Gastroenterologie Opernstrasse /ID# 163690	Kassel
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159379	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Koeln /ID# 164993	Köln	Nordrhein-Westfalen
Germany	EUGASTRO GmbH /ID# 219071	Leipzig
Germany	Klinikum Lueneburg /ID# 163692	Lueneburg
Germany	Universitatsklinikum Mannheim /ID# 162039	Mannheim	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Minden /ID# 162037	Minden
Germany	LMU Klinikum Campus Grosshadern /ID# 210484	München
Germany	Universitaetsklinikum Regensburg /ID# 163693	Regensburg
Germany	Universitaetsklinikum Ulm /ID# 164994	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217479	Athens
Greece	General Hospital of Athens Ippokratio /ID# 229190	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 206438	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170910	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 165327	Heraklion	Kriti
Greece	Tzaneio general hospital of Piraeus /ID# 206437	Piraeus	Attiki
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 165313	Pireaus
Greece	Theageneio Anticancer Hospital /ID# 165329	Thessaloniki
Israel	Soroka University Medical Center /ID# 171093	Be'er Sheva	HaDarom
Israel	Rambam Health Care Campus /ID# 171096	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 171092	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 163543	Jerusalem
Israel	Rabin Medical Center /ID# 167402	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 211279	Ramat Gan	Tel-Aviv
Italy	Ospedale Sant Orsola Malpighi /ID# 155627	Bologna	Emilia-Romagna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 164039	Catania
Italy	University of Catanzaro /ID# 200124	Catanzaro	Calabria
Italy	Ospedale Policlinico San Martino /ID# 164030	Genoa	Genova
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155623	Milano
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 170959	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 201818	Modena
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164029	Negrar	Verona
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211450	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 155628	Rome	Lazio
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 158020	Rome	Roma
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171223	Rome	Lazio
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 163994	Rome	Lazio
Italy	UOC Medicina Interna e Gastroe /ID# 155624	Rome
Italy	Istituto Clinico Humanitas /ID# 155626	Rozzano	Milano
Japan	Tokatsu Tsujinaka Hospital /ID# 164310	Abiko-shi	Chiba
Japan	Asahikawa Medical University Hospital /ID# 164324	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 164225	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 209633	Chiba-shi	Chiba
Japan	Fukuoka University Chikushi Hospital /ID# 209056	Chikushino-shi	Fukuoka
Japan	St.Luke's International Hospital /ID# 225969	Chuo-ku	Tokyo
Japan	Fukuoka University Hospital /ID# 226723	Fukuoka-shi	Fukuoka
Japan	Saiseikai Fukuoka Genaral Hospital /ID# 225640	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 164315	Fukuyama-shi	Hiroshima
Japan	Gifu University Hospital /ID# 208490	Gifu-shi	Gifu
Japan	Tokai University Hachioji Hospital /ID# 227102	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 226729	Hamamatsu-shi	Shizuoka
Japan	Matsuda Hospital /ID# 226831	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Hirosaki General Medical Center /ID# 164216	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 164240	Hiroshima-shi	Hiroshima
Japan	Tokai University Hospital /ID# 209207	Isehara-shi	Kanagawa
Japan	Teikyo University Hospital /ID# 225594	Itabashi-ku	Tokyo
Japan	Sameshima Hospital /ID# 211182	Kagoshima-shi	Kagoshima
Japan	Gokeikai Ofuna Chuo Hospital /ID# 169296	Kamakura-shi	Kanagawa
Japan	Kanazawa University Hospital /ID# 169221	Kanazawa-shi	Ishikawa
Japan	Nara Medical University Hospital /ID# 169222	Kashihara-shi	Nara
Japan	Tsujinaka Hospital Kashiwanoha /ID# 225968	Kashiwa-shi	Chiba
Japan	St. Marianna University Hospital /ID# 226730	Kawasaki-shi	Kanagawa
Japan	Aoyama Clinic /ID# 164236	Kobe-shi	Hyogo
Japan	Kurume University Hospital /ID# 164237	Kurume-shi	Fukuoka
Japan	Kitasato University Kitasato Institute Hospital /ID# 164222	Minato-ku	Tokyo
Japan	The Jikei University Hospital /ID# 164279	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 164226	Mitaka-shi	Tokyo
Japan	Aichi Medical University Hospital /ID# 164227	Nagakute-shi	Aichi
Japan	Nagasaki University Hospital /ID# 205326	Nagasaki-shi	Nagasaki
Japan	Nagoya City University Hospital /ID# 164229	Nagoya shi	Aichi
Japan	Daido Clinic /ID# 211478	Nagoya-shi	Aichi
Japan	Nagoya University Hospital /ID# 164230	Nagoya-shi	Aichi
Japan	Hyogo Medical University Hospital /ID# 164238	Nishinomiya-shi	Hyogo
Japan	Ogaki Municipal Hospital /ID# 226009	Ogaki-shi	Gifu
Japan	Kinshukai Infusion Clinic /ID# 226992	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 164323	Otsu-shi	Shiga
Japan	Saga University Hospital /ID# 209273	Saga-shi	Saga
Japan	Kitasato University Hospital /ID# 169223	Sagamihara-shi	Kanagawa
Japan	Tokitokai Tokito clinic /ID# 164218	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 164219	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164215	Sapporo-shi	Hokkaido
Japan	Sapporo Higashi Tokushukai Hospital /ID# 208493	Sapporo-shi	Hokkaido
Japan	Sapporo IBD Clinic /ID# 225967	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 164278	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 164276	Sendai-shi	Miyagi
Japan	NTT Medical Center Tokyo /ID# 225595	Shinagawa-ku	Tokyo
Japan	Keio University Hospital /ID# 203630	Shinjuku-ku	Tokyo
Japan	Tokuyama Central Hospital /ID# 226857	Shunan-shi	Yamaguchi
Japan	NHO Shizuoka Medical Center /ID# 164314	Sunto-gun	Shizuoka
Japan	National Hospital Organization Takasaki General Medical Center /ID# 164312	Takasaki-shi	Gunma
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 226036	Takatsuki-shi	Osaka
Japan	Fujita Health University Hospital /ID# 164313	Toyoake-shi	Aichi
Japan	Mie University Hospital /ID# 203635	Tsu-shi	Mie
Japan	Japanese Red Cross Wakayama Medical Center /ID# 171196	Wakayama-shi	Wakayama
Japan	Wakayama Medical University Hospital /ID# 169485	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 171481	Yamagata-shi	Yamagata
Japan	Yokkaichi Hazu Medical Center /ID# 164316	Yokkaichi-shi	Mie
Japan	Colo-proctology Center Matsushima Clinic /ID# 225915	Yokohama-shi	Kanagawa
Japan	Matsushima Hospital /ID# 254448	Yokohama-shi	Kanagawa
Japan	Showa University Fujigaoka Hospital /ID# 209606	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 158665	Busan
Korea, Republic of	Inje University Haeundae Hospital /ID# 203027	Busan
Korea, Republic of	Pusan National University Hospital /ID# 158670	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 158662	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242379	Daejeon
Korea, Republic of	Hanyang University Gurihospital /ID# 158661	Guri	Gyeonggido
Korea, Republic of	CHA University Bundang Medical Center /ID# 158669	Seongnam si	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 158666	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 158663	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 158660	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital /ID# 158664	Suwon	Gyeonggido
Latvia	Pauls Stradins Clinical University Hospital /ID# 160205	Riga
Latvia	VCA Polyclinic Aura /ID# 160204	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 201142	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 201144	Vilnius
Mexico	JM Research SC /ID# 206518	Cuernavaca	Morelos
Mexico	Health Pharma Professional Research S.A de C.V /ID# 206516	Del. Benito Juárez
Mexico	Unidad de Atencion Medica e Investigacion en Salud /ID# 206515	Merida	Yucatan
Netherlands	Academisch Medisch Centrum /ID# 157965	Amsterdam
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 163738	Tilburg
New Zealand	Christchurch Hospital /ID# 205337	Christchurch	Canterbury
New Zealand	Waikato Hospital /ID# 212788	Hamilton	Waikato
New Zealand	Hutt Hospital /ID# 212787	Lower Hutt
New Zealand	Wellington Regional Hospital /ID# 205338	Newtown	Wellington
New Zealand	Dunedin Hospital /ID# 212791	Otago
New Zealand	Tauranga Hospital /ID# 212793	Tauranga South	Bay Of Plenty
Poland	Vitamed Galaj i Cichomski Sp.j. /ID# 213358	Bydgoszcz	Kujawsko-pomorskie
Poland	NZOZ All-Medicus /ID# 170282	Katowice	Slaskie
Poland	Centrum Medyczne Plejady /ID# 170635	Krakow	Malopolskie
Poland	Endoskopia Sp. z o.o. /ID# 170284	Sopot	Pomorskie
Poland	Gastromed Sp. z o.o /ID# 231065	Torun	Kujawsko-pomorskie
Poland	H-T. Centrum Medyczne - Endoterapia /ID# 231501	Tychy	Slaskie
Poland	WIP Warsaw IBD Point Profesor Kierkus /ID# 216103	Warsaw	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 170283	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 170285	Warszawa	Mazowieckie
Poland	NZOZ Vivamed Jadwiga Miecz /ID# 216308	Warszawa	Mazowieckie
Poland	Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 170286	Warszawa	Mazowieckie
Poland	Vistamed /ID# 210106	Wroclaw	Dolnoslaskie
Portugal	Hospital Garcia de Orta, EPE /ID# 165579	Almada
Portugal	Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166050	Coimbra
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165576	Guimaraes	Braga
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165578	Lisboa
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166563	Portimão	Faro
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165577	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 166048	Santa Maria Da Feira	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 166049	Viseu
Puerto Rico	Ponce Medical School Foundation /ID# 222825	Ponce
Puerto Rico	VA Caribbean Healthcare System /ID# 222779	San Juan
Romania	Fundeni Clinical Institute /ID# 171259	Bucharest
Romania	Fundeni Clinical Institute /ID# 224155	Bucharest
Romania	Sana Monitoring /Id# 224154	Bucharest
Romania	Clinica GASTRO MED SRL /ID# 224156	Cluj-Napoca	Cluj
Romania	Cabinet Particular Policlinic Algomed /ID# 171260	Timi?oara
Romania	Duplicate_Centrul Medical Tuculanu SRL /ID# 171263	Timisoara
Russian Federation	Interdisctrict Multidisciplinary Hospital /ID# 204921	Anzorey	Kabardino-Balkarskaya Respublika
Russian Federation	Clinic of New Technologies of Medicine /ID# 204926	Dzerzhinskiy
Russian Federation	Immanuel Kant Baltic Federal University /ID# 204920	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kuzbass Regional Clinical Hospital /ID# 165759	Kemerovo	Kemerovskaya Oblast
Russian Federation	Arsvita Clinic /ID# 208947	Korolev	Moskovskaya Oblast
Russian Federation	Central Clinical Hospital RZHD Medicine /ID# 204922	Moscow
Russian Federation	First Moscow State Medical University n.a I.M. Sechenov /ID# 204981	Moscow
Russian Federation	National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203513	Moscow
Russian Federation	GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233974	Nalchik	Kabardino-Balkarskaya Respublika
Russian Federation	Novosibirski Gastrocenter /ID# 229852	Novosibirsk
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227456	Perm	Permskiy Kray
Russian Federation	Euromedservice /ID# 204918	Pushkin
Russian Federation	Uninova Medical Center /ID# 229786	Saint Petersburg	Leningradskaya Oblast
Russian Federation	City Clinical Hospital #40 /ID# 204927	Sestroretsk	Sankt-Peterburg
Russian Federation	International Medical Center SOGAZ /ID# 206832	St. Petersburg
Russian Federation	Regional Clinical Hospital #1 /ID# 165763	Tyumen	Tyumenskaya Oblast
Russian Federation	Ulyanovsk Regional Clinical Hospital /ID# 204923	Ulyanovsk
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 202060	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 200150	Belgrade	Beograd
Serbia	Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224927	Belgrade
Serbia	University Clinical Center Serbia /ID# 200153	Belgrade	Beograd
Serbia	General Hospital Leskovac /ID# 224198	Leskovac
Serbia	Clinical Center Vojvodina /ID# 156876	Novi Sad	Vojvodina
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 206563	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164348	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 206603	Nitra
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224100	Nove Zamky
Slovakia	GASTRO I., s.r.o. /ID# 164345	Presov
Slovenia	Univ Medical Ctr Ljubljana /ID# 210628	Ljubljana
South Africa	Farmovs (Pty) Ltd /Id# 207538	Bloemfontein	Free State
South Africa	Allergy & Immunology (AIU) /ID# 171439	Cape Town	Western Cape
South Africa	Dr JP Wright /ID# 171142	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 171141	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 229906	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 239825	Johannesburg	Gauteng
Spain	Hospital Clinic de Barcelona /ID# 159462	Barcelona
Spain	Hospital Universitario Reina Sofia /ID# 167062	Cordoba
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159463	Ferrol	A Coruna
Spain	Hospital Universitario de Cabuenes /ID# 170745	Gijon	Asturias
Spain	Hospital Universitario La Paz /ID# 159471	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159466	Majadahonda	Madrid
Spain	Complejo Hospitalario Universitario de Pontevedra /ID# 216183	Pontevedra
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159473	Sabadell	Barcelona
Spain	Hospital Universitario de Salamanca /ID# 159469	Salamanca
Spain	Hospital Universitario Virgen Macarena /ID# 159969	Sevilla
Spain	Hospital Alvaro Cunqueiro CHUVI /ID# 167359	Vigo	Pontevedra
Spain	Hospital Universitario Miguel Servet /ID# 159468	Zaragoza
Sweden	Alingsas lasarett /ID# 202075	Alingsas	Vastra Gotalands Lan
Sweden	Sahlgrenska University Hospital Molndal /ID# 202841	Molndal	Vastra Gotalands Lan
Sweden	Danderyds sjukhus AB /ID# 202036	Stockholm
Switzerland	Inselspital, Universitätsspital Bern /ID# 202909	Bern
Switzerland	Universitatsspital Zurich /ID# 202908	Zurich	Zuerich
Taiwan	China Medical University Hospital /ID# 160194	Taichung
Taiwan	Chung Shan Medical University Hospital /ID# 171426	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 171433	Taichung
Taiwan	Taipei Veterans General Hosp /ID# 171436	Taipei
Taiwan	National Taiwan University Hospital /ID# 162188	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 222878	Taoyuan City
Turkey	Ankara Univ Medical Faculty /ID# 167205	Ankara
Turkey	Inonu Universitesi Turgut Ozal /ID# 203980	Battalgazi/malatya
Turkey	Uludag University Medical Faculty /ID# 204179	Bursa
Turkey	Firat University Medical Facul /ID# 171285	Elazig
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167202	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171290	Istanbul
Turkey	Acibadem Kozyatagi Hospital /ID# 213277	Kadikoy	Istanbul
Turkey	Erciyes University Medical Fac /ID# 171283	Melikgazi	Kayseri
Turkey	Sisli Etfal Train & Res Hosp /ID# 171415	Sisli
Ukraine	CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203366	Ivano-frankivsk
Ukraine	Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224349	Kherson
Ukraine	CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224344	Kyiv
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 224347	Kyiv
Ukraine	Medical Center "OK!Clinic+" /ID# 205484	Kyiv
United Kingdom	Barnsley Hospital NHS Foundation Trust /ID# 202771	Barnsley
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 158046	Cambridge
United Kingdom	NHS Lothian /ID# 208801	Edinburgh
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust /ID# 157614	Exeter	Devon
United Kingdom	Liverpool University Hospitals NHS Foundation Trust /ID# 203860	Liverpool
United Kingdom	Barts Health NHS Trust /ID# 157617	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 158762	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158047	Newcastle upon Tyne
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 210814	Southampton	Hampshire
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 208379	Tooting
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 159430	Ann Arbor	Michigan
United States	Inquest Clinical Research /ID# 165686	Baytown	Texas
United States	Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164257	Boston	Massachusetts
United States	GI Alliance /ID# 209799	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209951	Cedar Park	Texas
United States	Atrium Health Carolinas Medical Center /ID# 158543	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 160300	Chesterfield	Michigan
United States	The University of Chicago Medical Center /ID# 160511	Chicago	Illinois
United States	South Lake Pain Institute, Inc /ID# 162859	Clermont	Florida
United States	Cleveland Clinic Main Campus /ID# 209235	Cleveland	Ohio
United States	Peak Gastroenterology Associates, PC /ID# 165838	Colorado Springs	Colorado
United States	Optimed Research, Ltd. /ID# 167112	Columbus	Ohio
United States	The Ohio State University /ID# 164713	Columbus	Ohio
United States	Gastro One /ID# 160373	Cordova	Tennessee
United States	Southern California Res. Ctr. /ID# 169659	Coronado	California
United States	Plains Clinical Research Center, LLC /ID# 169729	Fargo	North Dakota
United States	DHAT Research Institute /ID# 158235	Garland	Texas
United States	Gastroenterology Associates, P.A. of Greenville /ID# 160457	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 160287	Hamden	Connecticut
United States	Penn State Milton S. Hershey Medical Center /ID# 230474	Hershey	Pennsylvania
United States	Houma Digestive Health Special /ID# 158377	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 158230	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201221	Houston	Texas
United States	Vilo Research Group Inc /ID# 207657	Houston	Texas
United States	Indiana University /ID# 167250	Indianapolis	Indiana
United States	Hoag Memorial Hosp Presbyterian /ID# 218347	Irvine	California
United States	East Tennessee Research Institute /ID# 168744	Johnson City	Tennessee
United States	Univ Kansas Med Ctr /ID# 226601	Kansas City	Kansas
United States	UC San Diego Health System /ID# 160430	La Jolla	California
United States	Rocky Mountain Pediatric Gastroenterology /ID# 207173	Lone Tree	Colorado
United States	United Medical Doctors /ID# 158574	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934	Los Angeles	California
United States	Robley Rex VA Medical Center /ID# 218647	Louisville	Kentucky
United States	Caprock Gastro Research, LLC /ID# 215433	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 160513	Macon	Georgia
United States	Ctr for Advanced Gastroenterol /ID# 202820	Maitland	Florida
United States	Great Lakes Gastroenterology Research, LLC /ID# 201778	Mentor	Ohio
United States	Coral Research Clinic /ID# 158608	Miami	Florida
United States	South Florida Research Ph I-IV, Inc. /ID# 161844	Miami	Florida
United States	University of Miami /ID# 160456	Miami	Florida
United States	Gastroenterology Group Naples /ID# 165210	Naples	Florida
United States	Vanderbilt University Medical Center /ID# 160567	Nashville	Tennessee
United States	Yale Univ Digestive Diseases /ID# 213265	New Haven	Connecticut
United States	Delricht Research /ID# 206817	New Orleans	Louisiana
United States	Nola Research Works, LLC /ID# 161356	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 161945	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 161929	New York	New York
United States	Lenox Hill Hospital /ID# 168469	New York	New York
United States	Manhattan Clinical Research, LLC /ID# 211803	New York	New York
United States	Weill Cornell Medicine /ID# 165884	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 171128	North Massapequa	New York
United States	DM Clinical Research/Southwest /ID# 165009	Oak Lawn	Illinois
United States	Advanced Research Institute /ID# 160465	Ogden	Utah
United States	Digestive Disease Specialists /ID# 170777	Oklahoma City	Oklahoma
United States	Quality Clinical Research Inc. /ID# 167312	Omaha	Nebraska
United States	Advent Health /ID# 160393	Orlando	Florida
United States	Endoscopic Research, Inc. /ID# 206709	Orlando	Florida
United States	Omega Research Group /ID# 203105	Orlando	Florida
United States	University of Pennsylvania /ID# 166262	Philadelphia	Pennsylvania
United States	Gastroenterology Consultants of Southwest Virginia /ID# 218142	Roanoke	Virginia
United States	Mayo Clinic - Rochester /ID# 200455	Rochester	Minnesota
United States	University of Rochester Medical Center /ID# 161660	Rochester	New York
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 161364	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 168774	San Antonio	Texas
United States	UCSF Center for Colitis and Crohn's Disease /ID# 201209	San Francisco	California
United States	Virginia Mason Medical Center /ID# 160432	Seattle	Washington
United States	Louisiana Research Center, LLC /ID# 201205	Shreveport	Louisiana
United States	Lenus Research & Medical Group /ID# 169727	Sweetwater	Florida
United States	ProMedica Physicians Digestive Healthcare /ID# 215622	Sylvania	Ohio
United States	AdventHealth Tampa /ID# 170482	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 201794	Tampa	Florida
United States	Baylor Scott & White Center for Diagnostic Medicine /ID# 204132	Temple	Texas
United States	Cotton O'Neil Clinical Research Center, Digestive Health /ID# 160367	Topeka	Kansas
United States	Adult Gastroenterology Associates - Gen 1 Research /ID# 208873	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 166799	Tyler	Texas
United States	Gastro Health & Nutrition - Victoria /ID# 164308	Victoria	Texas
United States	Cedars-Sinai Medical Center-West Hollywood /ID# 163848	West Hollywood	California
United States	Digestive Disease Associates, LTD /ID# 232406	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,  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: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score	Clinical remission per Adapted Mayo Score.	Week 52
Primary	Percentage of Participants with Adverse Events (AE)	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Week 300
Secondary	Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement	Endoscopic improvement per endoscopy subscore.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement	Percentage of participants achieving histologic-endoscopic mucosal improvement.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission per endoscopy subscore.	Week 52
Secondary	Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days	Clinical remission per Adapted Mayo Score.	Week 52
Secondary	Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0	Clinical remission per Adapted Mayo Score.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency	Percentage of participants achieving no bowel urgency.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain	Percentage of participants achieving no abdominal pain.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission	Percentage of participants achieving histologic-endoscopic mucosal remission per endoscopy subscore.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0	Endoscopic improvement per endoscopy subscore.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score	Clinical response per Adapted Mayo Score.	Week 52
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.	Week 0 to Week 52
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 (Week 0) to Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements	Percentage of participants achieving no nocturnal bowel movements.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving No Tenesmus	Percentage of participants achieving no tenesmus.	Week 52
Secondary	Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week	Change in number of fecal incontinence episodes per week.	Baseline (Week 0) to Week 52
Secondary	Sub-Study 1: 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 (Week 0) to Week 52
Secondary	Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization	Participants with an exposure adjusted occurrence of UC event that results in admission to the hospital.	Through Week 52

External Links

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