A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Crohn's Disease Clinical Trial

— U-ENDURE  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03345823
• Other study ID #: M14-430
• Secondary ID: 2023-504951-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 21, 2018
• Est. completion date: September 3, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 747
• Est. completion date: September 3, 2027
• Est. primary completion date: September 3, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

For Substudy 1:

• Participant who achieve clinical response in Study M14-431 or Study M14-433.

• Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

• Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

• Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.

Exclusion Criteria:

For Substudies 1 and 2:

• Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

• Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.

• Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.

• Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Upadacitinib
Oral; Tablet
• Placebo for Upadacitinib
Oral; Tablet

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires /ID# 215542	Ciudad Autonoma Buenos Aires	Ciudad Autonoma De Buenos Aires
Argentina	Cemic /Id# 169183	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Gedyt /ID# 210018	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 169229	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 171251	Rosario	Santa Fe
Argentina	Cardio Alem /ID# 211283	San Isidro	Buenos Aires
Australia	Royal Adelaide Hospital /ID# 171508	Adelaide	South Australia
Australia	Box Hill Hospital /ID# 203735	Box Hill	Victoria
Australia	Concord Repatriation General Hospital /ID# 171506	Concord	New South Wales
Australia	Fiona Stanley Hospital /ID# 171507	Murdoch	Western Australia
Australia	Coral Sea Clinical Research institute /ID# 212989	North Mackay	Queensland
Australia	Mater Misericordiae Limited /ID# 204910	South Brisbane	Queensland
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 214468	Salzburg
Austria	Klinik Landstrasse /ID# 203438	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 169459	Vienna	Wien
Belgium	Duplicate_AZ Sint-Lucas /ID# 200296	Gent	Oost-Vlaanderen
Belgium	Universitair Ziekenhuis Leuven /ID# 200031	Leuven	Vlaams-Brabant
Belgium	CHU de Liège /ID# 200294	Liège	Liege
Belgium	Cliniques Universitaires UCL Saint-Luc /ID# 200293	Woluwe-Saint-Lambert	Bruxelles-Capitale
Belgium	Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 200295	Yvoir	Namur
Bosnia and Herzegovina	Duplicate_University Clinical Centre of the Republic of Srpska /ID# 200743	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 201346	Sarajevo
Bosnia and Herzegovina	Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217843	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla /ID# 210323	Tuzla	Tuzlanski
Brazil	Upeclin Fmb - Unesp /Id# 166860	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 166856	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166853	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 166855	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 166859	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 166854	Santo André	La Spezia
Brazil	Kaiser Clinica e Hospital Dia /ID# 166858	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Kaspela EOOD /ID# 167615	Plovdiv
Bulgaria	Duplicate_Second MHAT Sofia /ID# 167616	Sofia
Bulgaria	MHAT Trakia /ID# 201677	Stara Zagora
Canada	University of Calgary /ID# 166990	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 168047	Edmonton	Alberta
Canada	Covenant Health /ID# 166996	Edmonton	Alberta
Canada	University of Alberta Hospital /ID# 166987	Edmonton	Alberta
Canada	QEII - Health Sciences Centre /ID# 169308	Halifax	Nova Scotia
Canada	Hotel Dieu de Levis /ID# 166985	Lévis	Quebec
Canada	London Health Sciences Center- University Hospital /ID# 221039	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170122	Montreal	Quebec
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 170011	Montreal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 166984	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 169065	North Bay	Ontario
Canada	Taunton surgical centre /ID# 168045	Oshawa	Ontario
Canada	Ottawa Hospital Research Institute /ID# 212412	Ottawa	Ontario
Canada	CIUSSS de l'Estrie - CHUS /ID# 170936	Sherbrooke	Quebec
Canada	Medicor Research Inc /ID# 166997	Sudbury	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 166994	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates, Inc. /ID# 166988	Vaughan	Ontario
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 212421	Concepción
Chile	CEC SpA /ID# 169872	Ñuñoa
Chile	CTR Estudios Clinicos /ID# 203940	Providencia
Chile	Hospital Clinico Universidad De Los Andes /ID# 207463	Santiago
Chile	Research Group /ID# 203178	Santiago	Region Metropolitana De Santiago
China	Beijing Friendship Hospital /ID# 204175	Beijing	Beijing
China	The First Hospital of Jilin University /ID# 206865	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University /ID# 204057	Changsha
China	Nanfang Hospital of Southern Medical University /ID# 204056	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University /ID# 205227	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 204054	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204050	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 204058	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 204052	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital /ID# 204899	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204055	Shanghai	Shanghai
China	Duplicate_Tianjin Med Univ General Hosp /ID# 206979	Tianjin
China	Tongji Hospital Tongji Medical College of HUST /ID# 204051	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204065	Wuhan	Hubei
China	Zhongshan Hospital Xiamen University /ID# 204986	Xiamen	Fujian
Colombia	Hospital San Vicente de Paul /ID# 200020	Medellin	Antioquia
Colombia	Duplicate_Hospital Pablo Tobon Uribe /ID# 202403	Medellín	Antioquia
Croatia	Poliklinika Solmed /ID# 211517	Grad Zagreb
Croatia	UHC Split /ID# 171205	Split
Croatia	Zadar General Hospital /ID# 205533	Zadar
Croatia	Clinical Hospital Dubrava /ID# 171165	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 171194	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 171168	Zagreb	Grad Zagreb
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 224390	Ceske Budejovice
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 171564	Hradec Kralove
Czechia	ARTROSCAN s.r.o. /ID# 171575	Ostrava
Czechia	ResTrial s.r.o. /ID# 208651	Praha
Denmark	Herlev Hospital /ID# 200785	Herlev	Hovedstaden
Denmark	Nordsjaellands Hospital /ID# 200788	Hilleroed	Hovedstaden
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 200787	Hvidovre	Hovedstaden
Denmark	Duplicate_Sjaellands Universitets Hospital /ID# 200786	Roskilde	Sjælland
Egypt	Alexandria University /ID# 171008	Alexandria
Egypt	Alexandria University /ID# 171017	Alexandria
Egypt	Duplicate_Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209561	Alexandria
Egypt	Ain Shams University Faculty of Medicine /ID# 209566	Cairo
Egypt	Air Force Specialized Hospital /ID# 170993	Cairo
Egypt	National Hepatology and Tropical Medicine Research Institute /ID# 170991	Cairo
Egypt	National Liver Institute /ID# 170987	Menoufiya
Estonia	West Tallinn Central Hospital /ID# 202787	Tallinn
Estonia	Tartu University Hospital /ID# 203141	Tartu Linn	Tartumaa
France	CHU Amiens-Picardie Site Sud /ID# 171023	Amiens CEDEX 1	Somme
France	CHRU Tours - Hopital Trousseau /ID# 169783	Chambray Les Tours
France	Hopital Beaujon /ID# 171007	Clichy	Ile-de-France
France	Duplicate_CHU Henri Mondor /ID# 169782	Creteil
France	Duplicate_CHU Grenoble - Hopital Michallon /ID# 222403	La Tronche	Isere
France	CHRU Lille - Hopital Claude Huriez /ID# 206653	Lille	Nord
France	Duplicate_Hopital Saint Eloi /ID# 170039	Montpellier CEDEX 5	Herault
France	Clinique Jules Verne /ID# 222240	Nantes
France	Chu de Nice-Hopital Larchet Ii /Id# 171004	Nice	Alpes-Maritimes
France	Polyclinique Grand Sud /ID# 170037	Nimes Cedex
France	Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 207812	Pessac	Gironde
France	HCL - Hopital Lyon Sud /ID# 171030	Pierre Benite CEDEX	Rhone
France	Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 171027	St-Priest-en-Jarez
France	CHU Toulouse - Hopital Rangueil /ID# 169784	Toulouse	Haute-Garonne
France	CH Valenciennes /ID# 222399	Valenciennes	Nord
France	CHRU Nancy - Hopitaux de Brabois /ID# 170970	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 169271	Berlin
Germany	Gastroenterologie am Mexikoplatz /ID# 203574	Berlin
Germany	Universitaetsklinikum Erlangen /ID# 203550	Erlangen	Bayern
Germany	Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203569	Essen
Germany	Duplicate_Agaplesion Markus Krankenhaus /ID# 168753	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Frankfurt /ID# 203567	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Halle (Saale) /ID# 207453	Halle (Saale)
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168755	Kiel	Schleswig-Holstein
Germany	Universitatsklinikum Mannheim /ID# 168754	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 200212	Muenster
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206739	Saarbrücken	Saarland
Germany	Universitaetsklinikum Ulm /ID# 203554	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 167033	Athens
Greece	General Hospital of Athens Ippokratio /ID# 167032	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202102	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 167031	Heraklion	Kriti
Greece	Tzaneio general hospital of Piraeus /ID# 206435	Piraeus	Attiki
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 208823	Thessaloniki
Hong Kong	Queen Mary Hospital /ID# 171214	Hong Kong
Hong Kong	Tuen Mun Hospital /ID# 171213	Hong Kong
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont /ID# 200888	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 201886	Budapest
Hungary	Semmelweis Egyetem /ID# 210166	Budapest
Hungary	Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 200887	Debrecen
Hungary	Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 216420	Debrecen	Hajdu-Bihar
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205549	Encs	Borsod-Abauj-Zemplen
Hungary	Gyongyosi Bugat Pal Korhaz /ID# 201885	Gyongyos	Heves
Hungary	Kistarcsai Flor Ferenc Korhaz /ID# 206153	Kistarcsa
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont Mohacsi Korhaz /ID# 209440	Mohacs	Baranya
Hungary	Mentahaz Maganorvosi Kozpont /ID# 201888	Szekesfehervar
Hungary	Komarom-Esztergom Varmegyei Szent Borbala Korhaz (Clinexpert Tatabanya Kft.) /ID# 209896	Tatabanya	Komarom-Esztergom
Ireland	Mercy University Hospital /ID# 206512	Cork
Israel	Barzilai Medical Center /ID# 223374	Ashkelon	HaDarom
Israel	Soroka University Medical Center /ID# 169911	Be'er Sheva	HaDarom
Israel	Rabin Medical Center /ID# 202634	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 169926	Jerusalem	Yerushalayim
Israel	Duplicate_Kaplan Medical Center /ID# 170275	Rehovot	HaMerkaz
Israel	Tel Aviv Sourasky Medical Center /ID# 206450	Tel Aviv	Tel-Aviv
Israel	Yitzhak Shamir Medical Center /ID# 206449	Zerifin	HaMerkaz
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168155	Bologna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 168161	Catania
Italy	University of Catanzaro /ID# 201986	Catanzaro	Calabria
Italy	Policlinico San Martino/Univer /ID# 168162	Genova
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 170906	Milan	Milano
Italy	ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168149	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 200009	Modena
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168154	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168157	Palermo
Italy	Duplicate_Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202419	Pisa
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 168152	Rome	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 168150	Rome	Lazio
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 168151	Rome	Roma
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 168156	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 168153	Rozzano	Milano
Japan	Asahikawa Medical University Hospital /ID# 167148	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 165982	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital /ID# 214402	Chikushino-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 167155	Fukuyama-shi	Hiroshima
Japan	Tokai University Hachioji Hospital /ID# 165984	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 224402	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Hirosaki General Medical Center /ID# 165976	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 165998	Hiroshima-shi	Hiroshima
Japan	Idzuro Imamura Hospital /ID# 206655	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 227135	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital /ID# 206677	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 169212	Kanazawa-shi	Ishikawa
Japan	Nara Medical University Hospital /ID# 169213	Kashihara-shi	Nara
Japan	Aoyama Clinic /ID# 165993	Kobe-shi	Hyogo
Japan	Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 165994	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 165996	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hosital /ID# 165990	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 169887	Kyoto-shi	Kyoto
Japan	The Jikei University Hospital /ID# 167154	Minato-ku	Tokyo
Japan	Kyorin University - Mitaka Campus /ID# 165983	Mitaka
Japan	Iwate Medical University Uchimaru Medical Center /ID# 202465	Morioka-shi	Iwate
Japan	Aichi Medical University /ID# 165989	Nagakute	Aichi
Japan	Nagoya City University Hospital /ID# 165988	Nagoya shi	Aichi
Japan	Nagoya University Hospital /ID# 165987	Nagoya-shi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 170042	Niigata-shi	Niigata
Japan	Hyogo Medical University Hospital /ID# 165991	Nishinomiya-shi	Hyogo
Japan	Ishida Clinic of IBD and Gastroenterology /ID# 167149	Oita-shi	Oita
Japan	Duplicate_Okayama University Hospital /ID# 167354	Okayama-shi	Okayama
Japan	Kinshukai Infusion Clinic /ID# 218873	Osaka-shi	Osaka
Japan	Osaka Metropolitan University Hospital /ID# 165999	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 167157	Otsu-shi	Shiga
Japan	Tokitokai Tokito clinic /ID# 165977	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 165978	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165975	Sapporo-shi	Hokkaido
Japan	Sapporo IBD Clinic /ID# 223559	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 167152	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 167150	Sendai-shi	Miyagi
Japan	Tokyo Women's Medical University Hospital /ID# 205979	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital /ID# 169661	Suita-shi	Osaka
Japan	NHO Shizuoka Medical Center /ID# 167153	Sunto-gun	Shizuoka
Japan	National Hospital Organization Takasaki General Medical Center /ID# 167151	Takasaki-shi	Gunma
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 206323	Takatsuki-shi	Osaka
Japan	Toyama Prefectural Central Hospital /ID# 217836	Toyama-shi	Toyama
Japan	Toyohashi Municipal Hospital /ID# 200176	Toyohashi-shi	Aichi
Japan	Japanese Red Cross Wakayama Medical Center /ID# 200641	Wakayama-shi	Wakayama
Japan	Wakayama Medical University Hospital /ID# 169480	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 200158	Yamagata-shi	Yamagata
Japan	Kenseikai Dongo Hospital /ID# 208105	Yamatotakada-shi	Nara
Japan	Yokkaichi Hazu Medical Center /ID# 167201	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 167156	Yokohama shi	Kanagawa
Korea, Republic of	Kyungpook National University Hospital /ID# 207020	??	Daegu Gwang Yeogsi
Korea, Republic of	Dong-A University Medical Center /ID# 167568	Busan	Gyeongsangnamdo
Korea, Republic of	Inje University Haeundae Hospital /ID# 202631	Busan
Korea, Republic of	Pusan National University Hospital /ID# 167565	Busan
Korea, Republic of	Chungang University Hospital /ID# 207021	Dongjak-gu	Gyeonggido
Korea, Republic of	Duplicate_Hanyang University Gurihospital /ID# 167563	Guri	Gyeonggido
Korea, Republic of	Duplicate_CHA University Bundang Medical Center /ID# 167569	Seongnam si	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 167562	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 167564	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 167567	Seoul	Seoul Teugbyeolsi
Latvia	Duplicate_Digestive Disease Center Gastro /ID# 169518	Riga
Latvia	Pauls Stradins Clinical University Hospital /ID# 169494	Riga	Riga
Latvia	VCA Polyclinic Aura /ID# 169499	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207030	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 203269	Vilnius
Malaysia	Hospital Sultanah Bahiyah /ID# 201317	Alor Setar	Kedah
Malaysia	Universiti Sains Malaysia /ID# 200101	Kelantan
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170780	Kuala Lumpur	Selangor
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 206843	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 203496	Leon	Guanajuato
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207681	Victoria de Durango	Durango
Netherlands	Amsterdam UMC, locatie VUmc /ID# 166930	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis /ID# 166932	Amsterdam
Netherlands	Medisch Spectrum Twente /ID# 170299	Enschede
Netherlands	Zuyderland Medisch Centrum /ID# 169699	Heerlen	Limburg
Netherlands	Radboud Universitair Medisch Centrum /ID# 166931	Nijmegen	Gelderland
Poland	Malopolskie Centrum Kliniczne /ID# 202169	Krakow	Malopolskie
Poland	Duplicate_WIP Warsaw IBD Point Profesor Kierkus /ID# 224302	Warsaw	Mazowieckie
Poland	Centrum Medyczne Reuma Park /ID# 200489	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 200493	Warszawa	Mazowieckie
Poland	Vistamed /ID# 208571	Wroclaw	Dolnoslaskie
Portugal	Duplicate_Hospital Garcia de Orta, EPE /ID# 170209	Almada	Setubal
Portugal	Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170204	Guimaraes	Braga
Portugal	Hospital Egas Moniz /ID# 170232	Lisbon	Porto
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200608	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170211	Porto
Puerto Rico	Mindful Medical Research /ID# 203356	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166769	San Juan
Romania	Fundeni Clinical Institute /ID# 167831	Bucharest	Bucuresti
Romania	Duplicate_Clinica GASTRO MED SRL /ID# 206363	Cluj-Napoca	Cluj
Romania	Cabinet Particular Policlinic Algomed /ID# 167832	Timi?oara
Russian Federation	Immanuel Kant Baltic Federal University /ID# 203810	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 169589	Kazan	Tatarstan, Respublika
Russian Federation	Olla-Med Clinic /ID# 208723	Moscow
Russian Federation	P.A. Bayandin Murmansk Regiona /ID# 169590	Murmansk
Russian Federation	LLC Medical Center /ID# 209234	Novosibirsk	Novosibirskaya Oblast
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202989	Perm	Permskiy Kray
Russian Federation	Republican hospital named after V.A. Baranov /ID# 206497	Petrozavodsk
Russian Federation	Euromedservice /ID# 206608	Pushkin
Russian Federation	LLC Novaya Klinika /ID# 206613	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	X7 Clinical Research Center /ID# 216348	Saint Petersburg
Russian Federation	City Clinical Hospital No. 31 /ID# 208871	St. Petersburg
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202996	Stavropol	Stavropol Skiy Kray
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 168787	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 168216	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 168785	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 168217	Belgrade	Beograd
Serbia	Duplicate_University Clinical Center Kragujevac /ID# 205856	Kragujevac	Sumadijski Okrug
Serbia	Duplicate_Clinical Center Vojvodina /ID# 168196	Novi Sad	Vojvodina
Singapore	Gleneagles Medical Centre /ID# 206019	Singapore
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 205739	Singapore
Singapore	Tan Tock Seng Hospital /ID# 203158	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169960	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 170202	Nitra	Nitriansky Kraj
Slovenia	Univ Medical Ctr Ljubljana /ID# 211041	Ljubljana
South Africa	Farmovs (Pty) Ltd /Id# 207534	Bloemfontein	Free State
South Africa	Allergy & Immunology (AIU) /ID# 171427	Cape Town	Western Cape
South Africa	Dr JP Wright /ID# 170882	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 169851	Cape Town	Western Cape
South Africa	Lenasia Clinical Trial Centre /ID# 205143	Johannesburg	Gauteng
South Africa	Wits Clinical Research /ID# 170850	Johannesburg	Gauteng
Spain	Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 203909	A Coruna
Spain	Hospital Clinic de Barcelona /ID# 202726	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 202721	Barcelona
Spain	Hospital Universitario de Girona Doctor Josep Trueta /ID# 202644	Girona
Spain	Hospital Juan Ramon Jimenez /ID# 202727	Huelva
Spain	Hospital Universitario Dr. Negrin /ID# 202723	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario La Paz /ID# 202725	Madrid
Spain	Hospital Universitari Son Espases /ID# 201969	Palma de Mallorca	Illes Balears
Spain	Hospital Universitario de Navarra /ID# 202354	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca /ID# 206359	Salamanca
Spain	Hospital Universitario Marques de Valdecilla /ID# 202495	Santander	Cantabria
Spain	Hospital Universitario Virgen Macarena /ID# 202722	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 209658	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 202720	Valencia
Sweden	Alingsas lasarett /ID# 170814	Alingsas	Vastra Gotalands Lan
Sweden	Sodra Alvsborgs sjukhus /ID# 203078	Boras	Vastra Gotalands Lan
Sweden	Duplicate_Sahlgrenska University Hospital /ID# 169032	Gothenburg	Vastra Gotalands Lan
Sweden	Duplicate_Sahlgrenska University Hospital /ID# 169170	Gothenburg	Vastra Gotalands Lan
Sweden	Hallands Hospital Halmstad /ID# 170815	Halmstad	Hallands Lan
Sweden	Karolinska University Hospital Solna /ID# 224489	Solna	Stockholms Lan
Switzerland	Inselspital, Universitaetsspital Bern /ID# 170994	Bern
Switzerland	Duplicate_Universitatsspital Zurich /ID# 171000	Zurich	Zuerich
Taiwan	China Medical University Hospital /ID# 169803	Taichung
Taiwan	Taichung Veterans General Hospital /ID# 169802	Taichung
Taiwan	National Taiwan University Hospital /ID# 169805	Taipei City	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 169804	Taoyuan City
Turkey	Ankara Univ Medical Faculty /ID# 206408	Ankara
Turkey	Inonu Universitesi Turgut Ozal /ID# 201266	Battalgazi/malatya
Turkey	Mustafa Kemal University Medic /ID# 171328	Hatay
Turkey	Duplicate_Istanbul University Istanbul Medical Faculty /ID# 171365	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171326	Istanbul
Turkey	Acibadem Kozyatagi Hospital /ID# 209404	Kadikoy	Istanbul
Turkey	Duplicate_Erciyes University Medical Fac /ID# 171325	Melikgazi	Kayseri
Turkey	Mersin University Medical /ID# 171330	Mersin
Turkey	Sisli Etfal Train & Res Hosp /ID# 171327	Sisli	Istanbul
Turkey	Gazi Universitesi Tip Fakultes /ID# 217445	Yenimahalle	Ankara
Ukraine	Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167918	Kharkiv
Ukraine	Kyiv City Clinical Hospital No.18 /ID# 207890	Kyiv
Ukraine	Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203739	Kyiv
Ukraine	MNE KRC Kyiv Regional Clinical Hospital /ID# 202456	Kyiv
Ukraine	Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167917	Lviv
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222111	Vinnytsia	Vinnytska Oblast
United Kingdom	Royal United Hospitals Bath /ID# 169062	Bath
United Kingdom	Ulster Hospital - South Eastern Health & Social Care Trust /ID# 205324	Belfast
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 169058	Birmingham
United Kingdom	The Dudley Group NHS Foundation Trust /ID# 169057	Dudley
United Kingdom	London North West University Healthcare NHS Trust /ID# 169056	Harrow
United Kingdom	Barts Health NHS Trust /ID# 218830	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 169060	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169063	Newcastle upon Tyne
United Kingdom	Mersey and West Lancashire NHS teaching hospitals trust /ID# 209087	Prescot	Warrington
United Kingdom	Stockport NHS foundation trust /ID# 208717	Stockport
United Kingdom	Taunton and Somerset NHS Foundation Trust /ID# 209666	Taunton
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 205550	Tooting
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 171396	Warrington	Cheshire West And Chester
United Kingdom	The Royal Wolverhampton NHS Trust /ID# 171395	Wolverhampton
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164654	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 164719	Arlington	Texas
United States	Duplicate_Johns Hopkins University School of Medicine /ID# 211939	Baltimore	Maryland
United States	Inquest Clinical Research /ID# 164676	Baytown	Texas
United States	Texas Digestive Disease Consultants, PLLC dba GI Alliance /ID# 164728	Bellevue	Washington
United States	Treasure Valley Medical Research /ID# 215030	Boise	Idaho
United States	HP Clinical Research /ID# 164631	Bountiful	Utah
United States	Advantage Clinical Trials /ID# 168582	Bronx	New York
United States	Montefiore Medical Center - Moses Campus /ID# 166242	Bronx	New York
United States	NY Scientific /ID# 164630	Brooklyn	New York
United States	Duplicate_Lahey Hospital and Medical Center /ID# 214724	Burlington	Massachusetts
United States	GI Alliance /ID# 209803	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209954	Cedar Park	Texas
United States	Delsol Research Management, Ll /Id# 170164	Chandler	Arizona
United States	Pharmacorp Clinical Trials /ID# 165008	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 164632	Charlotte	North Carolina
United States	PMG Research of Charlotte /ID# 171178	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 170163	Chesterfield	Michigan
United States	Metropolitan Gastroenterology Group - Chevy Chase /ID# 164647	Chevy Chase	Maryland
United States	Duplicate_Rush University Medical Center /ID# 165470	Chicago	Illinois
United States	University of Chicago Medicine /ID# 165509	Chicago	Illinois
United States	Gastro Health Research /ID# 164668	Cincinnati	Ohio
United States	University of Cincinnati /ID# 164729	Cincinnati	Ohio
United States	Cleveland Clinic Main Campus /ID# 209230	Cleveland	Ohio
United States	Delta Waves, Inc. /ID# 164656	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates, PC /ID# 170166	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 171180	Columbia	Maryland
United States	Ohio State University/ Gastroe /ID# 170159	Columbus	Ohio
United States	Optimed Research, Ltd. /ID# 205625	Columbus	Ohio
United States	Advanced Research - Coral Springs /ID# 218019	Coral Springs	Florida
United States	Gastro One /ID# 164730	Cordova	Tennessee
United States	Southern California Res. Ctr. /ID# 169653	Coronado	California
United States	Citrus Valley Gastroenterology /ID# 166230	Covina	California
United States	Tri-State Gastroenterology /ID# 165469	Crestview Hills	Kentucky
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170161	Dallas	Texas
United States	Hometown Urgent Care and Resea /ID# 201289	Dayton	Ohio
United States	DuPage Medical Group /ID# 205320	Downers Grove	Illinois
United States	Cooper Gastroenterology at Fire Road /ID# 164641	Egg Harbor Township	New Jersey
United States	Dayton Gastroenterology, Inc. /ID# 167623	Englewood	Ohio
United States	MediSphere Medical Research Center /ID# 166233	Evansville	Indiana
United States	Plains Clinical Research Center, LLC /ID# 170169	Fargo	North Dakota
United States	Digestive Health Associates (DHA) - Farmington Hills /ID# 206101	Farmington Hills	Michigan
United States	Gastroenterology Associates, P.A. of Greenville /ID# 164643	Greenville	South Carolina
United States	Gastroenterology Center of Connecticut /ID# 164614	Hamden	Connecticut
United States	Houma Digestive Health Special /ID# 164727	Houma	Louisiana
United States	Baylor College of Medicine /ID# 164609	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201212	Houston	Texas
United States	GI Specialists of Houston /ID# 202340	Houston	Texas
United States	Indianapolis Gastroenterology /ID# 164649	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics /ID# 165405	Iowa City	Iowa
United States	Hoag Memorial Hosp Presbyterian /ID# 222538	Irvine	California
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 165295	Jackson	Mississippi
United States	Encore Borland-Groover Clinical Research /Id# 203500	Jacksonville	Florida
United States	East Tennessee Research Institute /ID# 203614	Johnson City	Tennessee
United States	United Health Services Hospitals, Inc /ID# 217483	Johnson City	New York
United States	UC San Diego Health System /ID# 164763	La Jolla	California
United States	NYU Langone Long Island Clinical Research Associates /ID# 164627	Lake Success	New York
United States	Las Vegas Medical Research /ID# 168551	Las Vegas	Nevada
United States	United Medical Doctors /ID# 207458	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640	Los Angeles	California
United States	Duplicate_University of Louisville /ID# 165391	Louisville	Kentucky
United States	University of Louisville Hospital /ID# 168520	Louisville	Kentucky
United States	Caprock Gastro Research - Lubbock - 80th Street /ID# 215436	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 165492	Macon	Georgia
United States	Ctr for Advanced Gastroenterol /ID# 165306	Maitland	Florida
United States	Great Lakes Gastroenterology Research, LLC /ID# 202006	Mentor	Ohio
United States	Coral Research Clinic /ID# 164604	Miami	Florida
United States	Crystal Pharmacology Research /ID# 166118	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital /ID# 202285	Milwaukee	Wisconsin
United States	Facey Medical Foundation /ID# 203138	Mission Hills	California
United States	CB Flock Research Corporation /ID# 166239	Mobile	Alabama
United States	East View Medical Research, LLC /ID# 171132	Mobile	Alabama
United States	United Medical Doctors - Murrieta /ID# 164602	Murrieta	California
United States	Quality Medical Research /ID# 205264	Nashville	Tennessee
United States	Vanderbilt University Medical Center /ID# 164607	Nashville	Tennessee
United States	Aquiant Research /ID# 205505	New Albany	Indiana
United States	Rutgers Robert Wood Johnson /ID# 166110	New Brunswick	New Jersey
United States	Nola Research Works, LLC /ID# 164612	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 164601	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 164692	New York	New York
United States	The Mount Sinai Hospital /ID# 170256	New York	New York
United States	Advanced Research Institute /ID# 164689	Ogden	Utah
United States	Digestive Disease Specialists /ID# 201063	Oklahoma City	Oklahoma
United States	CHI Health Research Center /ID# 168513	Omaha	Nebraska
United States	Quality Clinical Research Inc. /ID# 170162	Omaha	Nebraska
United States	Endoscopic Research, Inc. /ID# 206139	Orlando	Florida
United States	Omega Research Group /ID# 203482	Orlando	Florida
United States	Duplicate_Thomas Jefferson University /ID# 168003	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 168406	Philadelphia	Pennsylvania
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164752	Raleigh	North Carolina
United States	Rapid City Medical Center - GI Research /ID# 201733	Rapid City	South Dakota
United States	Gastoenterology Group of Rochester /ID# 166235	Rochester	New York
United States	Mayo Clinic - Rochester /ID# 164691	Rochester	Minnesota
United States	Gastroenterology Consultants, P.C /ID# 218218	Roswell	Georgia
United States	Duplicate_Care Access Research /ID# 164685	Salt Lake City	Utah
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 164675	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 169756	San Antonio	Texas
United States	Medical Assoc Research Grp /ID# 169704	San Diego	California
United States	UCSF Medical Center - Mount Zion /ID# 202372	San Francisco	California
United States	Univ of California San Francis /ID# 164653	San Francisco	California
United States	Care Access Research /ID# 167765	San Pablo	California
United States	HonorHealth Research Institute - Shea /ID# 164725	Scottsdale	Arizona
United States	University of Washington /ID# 164646	Seattle	Washington
United States	Virginia Mason Hospital & Medical Center /ID# 164862	Seattle	Washington
United States	Louisiana Research Center, LLC /ID# 164694	Shreveport	Louisiana
United States	Richmond University Medical Center /ID# 201858	Staten Island	New York
United States	Carl R. Meisner Medical Clinic /ID# 171057	Sugar Land	Texas
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702	Sun City	Arizona
United States	Atlanta Gastroenterology Spec /ID# 164698	Suwanee	Georgia
United States	Clinical Research of West Florida, Inc /ID# 205828	Tampa	Florida
United States	Clinical Research of West Florida, Inc /ID# 208119	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 203486	Tampa	Florida
United States	Duplicate_AdventHealth Tampa /ID# 171181	Tampa	Florida
United States	Center for Digestive Health /ID# 164726	Troy	Michigan
United States	Healthcare Research Consultant /ID# 166244	Tulsa	Oklahoma
United States	Options Health Research, LLC /ID# 164704	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 168679	Tyler	Texas
United States	The Vancouver Clinic, INC. PS /ID# 164874	Vancouver	Washington
United States	Gastro Health & Nutrition - Victoria /ID# 167810	Victoria	Texas
United States	Allegiance Research Specialists /ID# 165298	Wauwatosa	Wisconsin
United States	Velocity Clinical Research - Salt Lake City /ID# 166113	West Jordan	Utah
United States	Western States Clinical Res /ID# 164625	Wheat Ridge	Colorado
United States	Atrium Health Wake Forest Baptist Medical Center /ID# 164755	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,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Egypt,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  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 with Clinical Remission per Crohn's Disease Activity Index (CDAI)	Clinical remission per CDAI is defined as CDAI <150.	Week 52
Primary	Sub-Study 1: Percentage of Participants with Endoscopic Response	Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.	Week 52
Primary	Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.	Through Week 240
Secondary	Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)	Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.	Week 52
Secondary	Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)	Decrease of at least 100 points in CDAI from Baseline.	Week 52
Secondary	Sub-Study 1: Percentage of Participants with Endoscopic Remission	Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).	Week 52
Secondary	Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants	This is assessed in participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI <150.	Week 52
Secondary	Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission	Clinical remission per CDAI is defined as CDAI <150. Endoscopic remission is defined per SES-CD.	Week 52
Secondary	Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI	Clinical remission per CDAI is defined as CDAI <150 (as measured by the percentage of participants with clinical remission at Week 52 among those with clinical remission at Week 0).	Through Week 52
Secondary	Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.	This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.	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: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	The FACIT-F questionnaire was developed to assess fatigue.	Baseline (Week 0) to Week 52
Secondary	Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)	This is assessed by reviewing participant's hospitalization data.	Up to Week 52
Secondary	Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline	EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.	Week 52

External Links

•   Related info