A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Crohn's Disease Clinical Trial

— U-EXCEL  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345849
• Other study ID #: M14-433
• Secondary ID: 2017-001240-35
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2017
• Est. completion date: January 13, 2022

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

Description:

This study includes two parts:

• Part 1: a randomized double-blind placebo-controlled induction period and

• Part 2: an extended treatment period for non-responders from Part 1.

In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for Crohn's disease [SES-CD] < 15 and ≥ 15), and number of prior biologics with prior inadequate response or intolerance (0, 1, > 1).

Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2 to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than Baseline).

Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week, double-blind, maintenance portion of Study M14-430 (NCT03345823).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: January 13, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of CD for at least 3 months prior to Baseline.

• Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.

• Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.

• Demonstrated an inadequate response or intolerance to one or more conventional and/or biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids, immunosuppressants or biologic therapies for CD), in the opinion of the investigator.

• Note: Participants who have had inadequate response or intolerance to conventional therapy who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease).

• If female, participant must meet the contraception recommendations.

Exclusion Criteria:

• Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

• Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).

• Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum, or any other manifestation that might require surgery while enrolled in the study.

• Participant with ostomy or ileoanal pouch.

• Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.

• Screening laboratory and other analyses show abnormal results.

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# 215541	Ciudad Autonoma Buenos Aires	Ciuadad Autonoma De Buenos Aires
Argentina	Cemic /Id# 169182	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Gedyt /ID# 210020	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 169230	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 171252	Rosario	Santa Fe
Argentina	Cardio Alem /ID# 211285	San Isidro	Buenos Aires
Australia	Royal Adelaide Hospital /ID# 171514	Adelaide	South Australia
Australia	Box Hill Hospital /ID# 203736	Box Hill	Victoria
Australia	Concord Repatriation General Hospital /ID# 171512	Concord	New South Wales
Australia	Fiona Stanley Hospital /ID# 171513	Murdoch	Western Australia
Australia	Coral Sea Clinical Research institute /ID# 212988	North Mackay	Queensland
Australia	Mater Misericordiae Limited /ID# 204909	South Brisbane	Queensland
Austria	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470	Salzburg
Austria	Medizinische Universitaet Wien /ID# 169465	Vienna	Wien
Belgium	AZ Sint-Lucas /ID# 200302	Gent
Belgium	CHU de Liege Sart Tilman /ID# 217534	Liège	Liege
Belgium	UCL Saint-Luc /ID# 200303	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 208051	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 203887	Sarajevo
Bosnia and Herzegovina	Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla /ID# 210325	Tuzla	Tuzlanski
Brazil	Upeclin Fmb - Unesp /Id# 166867	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 166863	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 166862	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 208323	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 166865	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Kaspela EOOD /ID# 167613	Plovdiv
Bulgaria	Duplicate_Second MHAT Sofia /ID# 167614	Sofia
Bulgaria	MHAT Trakia /ID# 201679	Stara Zagora
Canada	University of Calgary /ID# 166974	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 168044	Edmonton	Alberta
Canada	South Edmonton Gastroenterology Research Clinic /ID# 166978	Edmonton	Alberta
Canada	University of Alberta - Zeidler Ledcor Centre /ID# 166971	Edmonton	Alberta
Canada	QEII - Health Sciences Centre /ID# 169307	Halifax	Nova Scotia
Canada	CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969	Levis	Quebec
Canada	London Health Sciences Center /ID# 221038	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120	Montreal	Quebec
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 170119	Montreal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 166968	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 169066	North Bay	Ontario
Canada	Taunton Surgical Centre /ID# 168043	Oshawa	Ontario
Canada	Ottawa Hospital Research Institute /ID# 212414	Ottawa	Ontario
Canada	CIUSSS de l'Estrie - CHUS /ID# 170940	Sherbrooke	Quebec
Canada	Medicor Research Inc /ID# 166979	Sudbury	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 166975	Vancouver	British Columbia
Canada	Toronto Digestive Disease Asso /ID# 166972	Vaughan	Ontario
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 212423	Concepción
Chile	CTR Estudios Clinicos /ID# 203941	Providencia
Chile	Hospital Clinico Universidad De Los Andes /ID# 207466	Santiago
Chile	M y F Estudios Clínicos /ID# 169984	Santiago	Region Metropolitana Santiago
Chile	Research Group /ID# 203179	Santiago	Region Metropolitana De Santiago
China	Beijing Friendship Hospital /ID# 204173	Beijing
China	The First Hospital of Jilin University /ID# 206868	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University /ID# 204082	Changsha
China	Nanfang Hospital of Southern Medical University /ID# 204083	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University /ID# 205228	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 204077	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 204092	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital /ID# 204900	Nanjing	Jiangsu
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091	Shanghai	Shanghai
China	Duplicate_Tianjin Med Univ General Hosp /ID# 206994	Tianjin
China	Tongji Hospital Tongji Medical College of HUST /ID# 204088	Wuhan
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081	Wuhan	Hubei
China	Zhongshan Hospital Xiamen University /ID# 204984	Xiamen	Fujian
Colombia	Hospital Universitario San Vic /ID# 200029	Medellin
Colombia	Hospital Pablo Tobon Uribe /ID# 202404	Medellín	Antioquia
Croatia	UHC Split /ID# 171191	Split
Croatia	Zadar General Hospital /ID# 205536	Zadar
Croatia	Clinical Hospital Dubrava /ID# 171185	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 205535	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 171203	Zagreb	Grad Zagreb
Croatia	Poliklinika Solmed /ID# 211519	Zagreb	Grad Zagreb
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 224389	Ceske Budejovice
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 171401	Hradec Kralove
Czechia	ARTROSCAN s.r.o. /ID# 200790	Ostrava
Czechia	ResTrial s.r.o. /ID# 208653	Praha
Denmark	Herlev Hospital /ID# 202423	Herlev	Hovedstaden
Denmark	Nordsjaellands Hospital /ID# 202424	Hilleroed	Hovedstaden
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425	Hvidovre	Hovedstaden
Denmark	Duplicate_Sjaellands Universitets Hospital /ID# 209445	Roskilde	Sjælland
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564	Alexandria
Egypt	Air Force Specialized Hospital /ID# 170996	Cairo
Egypt	National Hepatology and Tropical Medicine Research Institute /ID# 170989	Cairo
Egypt	National Liver Institute /ID# 170988	Menoufiya
Estonia	West Tallinn Central Hospital /ID# 202785	Tallinn
France	CHU Grenoble - Hopital Michallon /ID# 219034	La Tronche
France	Clinique Jules Verne /ID# 219073	Nantes
France	CH Valenciennes /ID# 219035	Valenciennes
Germany	Gastroenterologie am Mexikoplatz /ID# 203575	Berlin
Germany	Universitaetsklinikum Erlangen /ID# 203552	Erlangen	Bayern
Germany	Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570	Essen
Germany	Agaplesion Markus Krankenhaus /ID# 168758	Frankfurt am Main
Germany	Universitaetsklinikum Frankfurt /ID# 203566	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Halle (Saale) /ID# 207455	Halle (Saale)
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757	Kiel	Schleswig-Holstein
Germany	Universitatsklinikum Mannheim /ID# 168759	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 200214	Muenster
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741	Saarbrücken	Saarland
Germany	Universitaetsklinikum Ulm /ID# 203560	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Ippokratio /ID# 167045	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 167044	Heraklion	Kriti
Greece	Tzaneio general hospital of Piraeus /ID# 206433	Piraeus	Attiki
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 208825	Thessaloniki
Hong Kong	Tuen Mun Hospital /ID# 171218	Hong Kong
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft. /ID# 201892	Budapest	Pest
Hungary	Semmelweis Egyetem /ID# 210167	Budapest
Hungary	Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 216419	Debrecen	Hajdu-Bihar
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547	Encs	Borsod-Abauj-Zemplen
Hungary	Bugat Pal Korhaz /ID# 201893	Gyöngyös	Heves
Hungary	Pest Megyei Flor Ferenc Korhaz /ID# 206154	Kistarcsa
Hungary	Mohacsi Korhaz /ID# 209441	Mohacs	Baranya
Hungary	Mentahaz Maganorvosi Kozpont /ID# 201895	Szekesfehervar
Hungary	Szent Borbala Korhaz /ID# 209897	Tatabanya	Komarom-Esztergom
Ireland	Mercy University Hospital /ID# 206511	Cork
Israel	Soroka University Medical Center /ID# 169913	Be'er Sheva	HaDarom
Israel	Assaf Harofeh Medical Center /ID# 204872	Be'Er Ya'Akov
Israel	Hadassah Medical Center-Hebrew University /ID# 169928	Jerusalem
Israel	Rabin Medical Center /ID# 202636	Petakh Tikva
Israel	Kaplan Medical Center /ID# 170276	Rehovot
Israel	Tel Aviv Sourasky Medical Center /ID# 204877	Tel Aviv-Yafo	Tel-Aviv
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187	Bologna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 168190	Catania
Italy	Policlinico San Martino/Univer /ID# 168191	Genova
Italy	ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181	Milano
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 170849	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena /ID# 201897	Modena
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189	Palermo
Italy	Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421	Pisa
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 168184	Rome	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 168188	Rome	Roma
Italy	Policlinico Universitario Campus Bio-Medico /ID# 168183	Rome	Lazio
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 168185	Rozzano	Milano
Japan	Asahikawa Medical University Hospital /ID# 167120	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 165965	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital /ID# 214404	Chikushino-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 167131	Fukuyama-shi	Hiroshima
Japan	Tokai University Hachioji Hospital /ID# 165967	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 224352	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Hirosaki General Medical Center /ID# 165961	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 166014	Hiroshima-shi	Hiroshima
Japan	Idzuro Imamura Hospital /ID# 206654	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 227137	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital /ID# 206675	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 169218	Kanazawa-shi	Ishikawa
Japan	Nara Medical University Hospital /ID# 169219	Kashihara-shi	Nara
Japan	Aoyama Clinic /ID# 166009	Kobe-shi	Hyogo
Japan	Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 166012	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 169889	Kyoto-shi	Kyoto
Japan	The Jikei University Hospital /ID# 167130	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 165966	Mitaka-shi	Tokyo
Japan	Iwate Medical University Uchimaru Medical Center /ID# 202464	Morioka-shi	Iwate
Japan	Aichi Medical University Hospital /ID# 165971	Nagakute-shi	Aichi
Japan	Nagoya City University Hospital /ID# 165970	Nagoya shi	Aichi
Japan	Nagoya University Hospital /ID# 165969	Nagoya-shi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 170045	Niigata-shi	Niigata
Japan	Hyogo College of Medicine College Hospital /Id# 165973	Nishinomiya-shi	Hyogo
Japan	Ishida Clinic of IBD and Gastroenterology /ID# 167121	Oita-shi	Oita
Japan	Okayama University Hospital /ID# 167356	Okayama-shi	Okayama
Japan	Kinshukai Infusion Clinic /ID# 218872	Osaka-shi	Osaka
Japan	Osaka Metropolitan University Hospital /ID# 166015	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 167129	Otsu-shi	Shiga
Japan	Tokitokai Tokito clinic /ID# 165962	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 165963	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960	Sapporo-shi	Hokkaido
Japan	Sapporo IBD Clinic /ID# 223561	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 167124	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 167122	Sendai-shi	Miyagi
Japan	Tokyo Women's Medical University Hospital /ID# 205980	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital /ID# 169663	Suita-shi	Osaka
Japan	NHO Shizuoka Medical Center /ID# 167125	Sunto-gun	Shizuoka
Japan	National Hospital Organization Takasaki General Medical Center /ID# 167127	Takasaki-shi	Gunma
Japan	Osaka Medical and Pharmaceutical University Hospital /ID# 206326	Takatsuki-shi	Osaka
Japan	Toyama Prefectural Central Hospital /ID# 217834	Toyama-shi	Toyama
Japan	Toyohashi Municipal Hospital /ID# 200175	Toyohashi-shi	Aichi
Japan	Japanese Red Cross Wakayama Medical Center /ID# 200643	Wakayama-shi	Wakayama
Japan	Wakayama Medical University Hospital /ID# 169482	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 200157	Yamagata-shi	Yamagata
Japan	Kenseikai Dongo Hospital /ID# 208104	Yamatotakada-shi	Nara
Japan	Yokkaichi Hazu Medical Center /ID# 167196	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 167128	Yokohama shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 167591	Busan
Korea, Republic of	Inje University Haeundae Hospital /ID# 202630	Busan
Korea, Republic of	Pusan National University Hospital /ID# 167589	Busan
Korea, Republic of	Kyungpook National University Hospital /ID# 207019	Daegu
Korea, Republic of	Hayang University GuriHospital /ID# 167587	Guri	Gyeonggido
Korea, Republic of	CHA University Bundang Medical Center /ID# 167592	Seongnam si	Gyeonggido
Korea, Republic of	Chung-Ang University Hostipal /ID# 207018	Seoul
Korea, Republic of	Kangbuk Samsung Hospital /ID# 167586	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 167588	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 167590	Seoul	Seoul Teugbyeolsi
Latvia	Digestive Disease Center Gastro /ID# 169508	Riga
Latvia	Pauls Stradins Clinical University Hospital /ID# 169519	Riga
Latvia	VCA Polyclinic Aura /ID# 169498	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936	Kaunas
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 203286	Vilnius
Malaysia	Hospital Sultanah Bahiyah /ID# 202626	Alor Setar	Kedah
Malaysia	Universiti Sains Malaysia /ID# 200102	Kelantan
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773	Kuala Lumpur	Selangor
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 203494	Leon	Guanajuato
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579	Victoria de Durango	Durango
Netherlands	Academisch Medisch Centrum /ID# 166927	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis /ID# 166929	Amsterdam
Netherlands	Medisch Spectrum Twente /ID# 170298	Enschede
Netherlands	Zuyderland Medisch Centrum /ID# 169700	Heerlen	Limburg
Netherlands	Radboud Universitair Medisch Centrum /ID# 166928	Nijmegen	Gelderland
Poland	Malopolskie Centrum Kliniczne /ID# 202167	Krakow	Malopolskie
Poland	WIP Warsaw IBD Point Profesor Kierkus /ID# 224301	Warsaw	Mazowieckie
Poland	Centrum Medyczne Reuma Park /ID# 200490	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 200491	Warszawa	Mazowieckie
Poland	Vistamed /ID# 208572	Wroclaw	Dolnoslaskie
Portugal	Hospital Garcia de Orta, EPE /ID# 170241	Almada
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245	Guimaraes	Braga
Portugal	Hospital Egas Moniz /ID# 170253	Lisbon	Porto
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248	Porto
Puerto Rico	Mindful Medical Research /ID# 203358	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771	San Juan
Romania	Clinica GASTRO MED SRL /ID# 206369	Cluj-Napoca	Cluj
Romania	Institutul Clinic Fundeni /ID# 167817	Sector 2	Bucuresti
Romania	Cabinet Particular Policlinic Algomed /ID# 167818	Timi?oara
Russian Federation	Immanuel Kant Baltic Federal University /ID# 203811	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 169638	Kazan	Tatarstan, Respublika
Russian Federation	Olla-Med Clinic /ID# 208720	Moscow
Russian Federation	P.A. Bayandin Murmansk Regiona /ID# 169639	Murmansk
Russian Federation	LLC Medical Center /ID# 209236	Novosibirsk	Novosibirskaya Oblast
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990	Perm	Permskiy Kray
Russian Federation	Republican hospital named after V.A. Baranov /ID# 206488	Petrozavodsk
Russian Federation	Euromedservice /ID# 206610	Pushkin
Russian Federation	LLC Novaya Klinika /ID# 206616	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	X7 Clinical Research Center /ID# 216350	Saint Petersburg
Russian Federation	City Clinical Hospital No. 31 /ID# 208868	St. Petersburg
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997	Stavropol	Stavropol Skiy Kray
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 168750	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 168214	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 168783	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 168215	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 205859	Kragujevac	Sumadijski Okrug
Serbia	Clinical Center Vojvodina /ID# 168213	Novi Sad	Vojvodina
Singapore	Gleneagles Medical Centre /ID# 206531	Singapore
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 217962	Singapore
Singapore	Tan Tock Seng Hospital /ID# 203160	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 170201	Nitra
Slovenia	Univ Medical Ctr Ljubljana /ID# 217795	Ljubljana
South Africa	Farmovs (Pty) Ltd /Id# 207535	Bloemfontein	Free State
South Africa	Allergy & Immunology (AIU) /ID# 171431	Cape Town	Western Cape
South Africa	Dr JP Wright /ID# 170887	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 169853	Cape Town	Western Cape
South Africa	Lenasia Clinical Trial Centre /ID# 205145	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 170852	Johannesburg	Gauteng
Spain	Hospital Universitario A Coruna - CHUAC /ID# 203910	A Coruna
Spain	Hospital Clinic de Barcelona /ID# 201990	Barcelona
Spain	Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645	Girona
Spain	Hospital Juan Ramon Jimenez /ID# 201995	Huelva
Spain	Hospital Universitario La Paz /ID# 201994	Madrid
Spain	Hospital Universitari Son Espases /ID# 201998	Palma de Mallorca	Illes Balears
Spain	Hospital Universitario de Navarra /ID# 202355	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca /ID# 206358	Salamanca
Spain	Hospital Universitario Virgen Macarena /ID# 201993	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 209657	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 201992	Valencia
Sweden	Alingsas lasarett /ID# 170826	Alingsas	Vastra Gotalands Lan
Sweden	Sodra Alvsborgs sjukhus /ID# 203077	Boras	Vastra Gotalands Lan
Sweden	Sahlgrenska University Hospital /ID# 169171	Gothenburg	Vastra Gotalands Lan
Sweden	Hallands Hospital Halmstad /ID# 170828	Halmstad	Hallands Lan
Sweden	Karolinska University Hospital Solna /ID# 224488	Solna	Stockholms Lan
Switzerland	Inselspital, Universitätsspital Bern /ID# 170997	Bern
Switzerland	Universitätsspital Zürich /ID# 170998	Zürich	Zuerich
Taiwan	Taichung Veterans General Hospital /ID# 169790	Taichung
Taiwan	China Medical University Hospital /ID# 169791	Taichung City
Taiwan	National Taiwan University Hospital /ID# 169792	Taipei City
Turkey	Ankara Univ Medical Faculty /ID# 206409	Ankara
Turkey	Inonu Universitesi Turgut Ozal /ID# 201268	Battalgazi/malatya
Turkey	Mustafa Kemal University Medic /ID# 171336	Hatay
Turkey	Istanbul University Istanbul Medical Faculty /ID# 171364	Istanbul
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332	Istanbul
Turkey	Acibadem Kozyatagi Hospital /ID# 209406	Kadikoy	Istanbul
Turkey	Erciyes University Medical Fac /ID# 171331	Melikgazi	Kayseri
Turkey	Mersin University Medical /ID# 171338	Mersin
Turkey	Sisli Etfal Train & Res Hosp /ID# 171334	Sisli
Turkey	Gazi Universitesi Tip Fakultes /ID# 217444	Yenimahalle
Ukraine	Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907	Kharkiv
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 207889	Kyiv
Ukraine	Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738	Kyiv	Kyivska Oblast
Ukraine	MNI KRC Kyiv Regional Clinical Hospital /ID# 202454	Kyiv
Ukraine	Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908	Lviv
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110	Vinnytsia
United Kingdom	Royal United Hospitals Bath /ID# 169074	Bath
United Kingdom	South Eastern Health and Social Care Trust /ID# 205323	Belfast	Antrim
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 169070	Birmingham
United Kingdom	The Dudley Group NHS Foundation Trust /ID# 169069	Dudley
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 169072	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075	Newcastle Upon Tyne
United Kingdom	Stockport NHS foundation trust /ID# 208719	Stockport
United Kingdom	Taunton and Somerset NHS Foundation Trust /ID# 209665	Taunton
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 205552	Tooting
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383	Warrington	Cheshire West And Chester
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086	Warrington	Cheshire West And Chester
United Kingdom	The Royal Wolverhampton NHS Trust /ID# 171382	Wolverhampton
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 164896	Arlington	Texas
United States	Johns Hopkins University School of Medicine /ID# 211941	Baltimore	Maryland
United States	Inquest Clinical Research /ID# 164785	Baytown	Texas
United States	Washington Gastroenterology /ID# 164824	Bellevue	Washington
United States	Treasure Valley Medical Research /ID# 215032	Boise	Idaho
United States	HP Clinical Research /ID# 164933	Bountiful	Utah
United States	Advantage Clinical Trials /ID# 168546	Bronx	New York
United States	Montefiore Medical Center - Moses Campus /ID# 166193	Bronx	New York
United States	NY Scientific /ID# 164931	Brooklyn	New York
United States	Lahey Hospital and Medical Center /ID# 214726	Burlington	Massachusetts
United States	Texas Digestive Disease Consultants /ID# 209801	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209953	Cedar Park	Texas
United States	Delsol Research Management, Ll /Id# 170145	Chandler	Arizona
United States	Pharmacorp Clinical Trials /ID# 164916	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 164932	Charlotte	North Carolina
United States	PMG Research of Charlotte /ID# 171160	Charlotte	North Carolina
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935	Chevy Chase	Maryland
United States	Rush University Medical Center /ID# 165497	Chicago	Illinois
United States	University of Chicago Medicine /ID# 165503	Chicago	Illinois
United States	Gastro Health Research /ID# 164791	Cincinnati	Ohio
United States	University of Cincinnati /ID# 164825	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc /ID# 205827	Clearwater	Florida
United States	Clinical Research of West Florida, Inc /ID# 208118	Clearwater	Florida
United States	Cleveland Clinic Main Campus /ID# 209231	Cleveland	Ohio
United States	Delta Waves, Inc. /ID# 164776	Colorado Springs	Colorado
United States	Peak Gastroenterology Associates, PC /ID# 170143	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 171161	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 205624	Columbus	Ohio
United States	The Ohio State University /ID# 170141	Columbus	Ohio
United States	Advanced Research - Coral Springs /ID# 218021	Coral Springs	Florida
United States	Southern California Res. Ctr. /ID# 169655	Coronado	California
United States	Citrus Valley Gastroenterology /ID# 166173	Covina	California
United States	Tri-State Gastroenterology /ID# 165496	Crestview Hills	Kentucky
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144	Dallas	Texas
United States	Hometown Urgent Care and Resea /ID# 201291	Dayton	Ohio
United States	DuPage Medical Group /ID# 205328	Downers Grove	Illinois
United States	AGA Clinical Research Associates, LLC /ID# 164769	Egg Harbor Township	New Jersey
United States	Dayton Gastroenterology, Inc. /ID# 167627	Englewood	Ohio
United States	MediSphere Medical Research Center /ID# 166175	Evansville	Indiana
United States	Plains Clinical Research Center, LLC /ID# 170140	Fargo	North Dakota
United States	Digestive Health Associates (DHA) - Farmington Hills /ID# 205793	Farmington Hills	Michigan
United States	Gastro One /ID# 164826	Germantown	Tennessee
United States	Gastroenterology Associates, P.A. of Greenville /ID# 164771	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 164926	Hamden	Connecticut
United States	CroNOLA, LLC /ID# 164823	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 164947	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201214	Houston	Texas
United States	CliniCore International, LLC /ID# 164902	Houston	Texas
United States	GI Specialists of Houston /ID# 202339	Houston	Texas
United States	Indianapolis Gastroenterology /ID# 164938	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics /ID# 165436	Iowa City	Iowa
United States	Hoag Memorial Hosp Presbyterian /ID# 222540	Irvine	California
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 165343	Jackson	Mississippi
United States	Encore Borland-Groover Clinical Research /Id# 203499	Jacksonville	Florida
United States	East Tennessee Research Institute /ID# 203613	Johnson City	Tennessee
United States	United Health Services Hospitals, Inc /ID# 217485	Johnson City	New York
United States	NYU Langone Long Island Clinical Research Associates /ID# 164927	Lake Success	New York
United States	Las Vegas Medical Research /ID# 168588	Las Vegas	Nevada
United States	United Medical Doctors /ID# 207449	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762	Los Angeles	California
United States	University of Louisville /ID# 165366	Louisville	Kentucky
United States	University of Louisville /ID# 168572	Louisville	Kentucky
United States	Caprock Gastro Research, LLC /ID# 215438	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 165478	Macon	Georgia
United States	Ctr for Advanced Gastroenterol /ID# 165353	Maitland	Florida
United States	Great Lakes Medical Research, LLC /ID# 202010	Mentor	Ohio
United States	Coral Research Clinic /ID# 164890	Miami	Florida
United States	Crystal Pharmacology Research /ID# 166081	Miami	Florida
United States	Facey Medical Foundation /ID# 203136	Mission Hills	California
United States	CB Flock Research Corporation /ID# 166185	Mobile	Alabama
United States	East View Medical Research, LLC /ID# 171176	Mobile	Alabama
United States	United Medical Doctors - Murrieta /ID# 164945	Murrieta	California
United States	Quality Medical Research /ID# 205263	Nashville	Tennessee
United States	Vanderbilt University Medical Center /ID# 164946	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson /ID# 166073	New Brunswick	New Jersey
United States	Nola Research Works, LLC /ID# 164759	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 164921	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 164782	New York	New York
United States	The Mount Sinai Hospital /ID# 170257	New York	New York
United States	Advanced Research Institute /ID# 164784	Ogden	Utah
United States	Digestive Disease Specialists /ID# 201064	Oklahoma City	Oklahoma
United States	Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578	Omaha	Nebraska
United States	Quality Clinical Research Inc. /ID# 170137	Omaha	Nebraska
United States	Endoscopic Research, Inc. /ID# 206136	Orlando	Florida
United States	Omega Research Maitland, LLC /ID# 203481	Orlando	Florida
United States	University of Pennsylvania /ID# 168430	Philadelphia	Pennsylvania
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904	Raleigh	North Carolina
United States	Rapid City Medical Center - GI Research /ID# 201735	Rapid City	South Dakota
United States	Gastoenterology Group of Rochester /ID# 166177	Rochester	New York
United States	Mayo Clinic - Rochester /ID# 164783	Rochester	Minnesota
United States	Gastroenterology Consultants PC - Roswell /ID# 218220	Roswell	Georgia
United States	Duplicate_Care Access Research /ID# 164794	Salt Lake City	Utah
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 164786	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 169755	San Antonio	Texas
United States	Medical Assoc Research Grp /ID# 169706	San Diego	California
United States	Ucsd /Id# 164910	San Diego	California
United States	Univ of California San Francis /ID# 164944	San Francisco	California
United States	Care Access Research /ID# 167767	San Pablo	California
United States	HonorHealth Research Institute - Shea /ID# 164821	Scottsdale	Arizona
United States	Virginia Mason Medical Center /ID# 164913	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 164894	Shreveport	Louisiana
United States	Richmond University Medical Center /ID# 201857	Staten Island	New York
United States	Carl R. Meisner Medical Clinic /ID# 201061	Sugar Land	Texas
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803	Sun City	Arizona
United States	Atlanta Gastroenterology Spec /ID# 164799	Suwanee	Georgia
United States	AdventHealth Tampa /ID# 171167	Tampa	Florida
United States	Clinical Research Trials of Florida, Inc. /ID# 203485	Tampa	Florida
United States	Center for Digestive Health /ID# 164822	Troy	Michigan
United States	Clin Res Inst of Michigan, LLC /ID# 170133	Troy	Michigan
United States	Healthcare Research Consultant /ID# 166195	Tulsa	Oklahoma
United States	Options Health Research, LLC /ID# 164820	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 168687	Tyler	Texas
United States	The Vancouver Clinic, INC. PS /ID# 164918	Vancouver	Washington
United States	Gastro Health & Nutrition - Victoria /ID# 167812	Victoria	Texas
United States	Allegiance Research Specialists /ID# 165346	Wauwatosa	Wisconsin
United States	Velocity Clinical Research - Salt Lake City /ID# 166076	West Jordan	Utah
United States	Western States Clinical Res /ID# 164760	Wheat Ridge	Colorado
United States	Wake Forest Baptist Medical Center /ID# 164908	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	Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12	The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12.; CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.	Week 12
Primary	Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12	The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF = 2.8 and average daily APS = 1.0 and neither worse than Baseline.; Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).; The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.	Week 12
Primary	Percentage of Participants With Endoscopic Response at Week 12	Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers.; The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.	Baseline and Week 12
Secondary	Percentage of Participants With Endoscopic Remission at Week 12	Endoscopic remission is defined as an SES-CD = 4 and at least 2 point reduction from Baseline and no subscore > 1 in any individual variable,as scored by independent external and blinded central readers.; The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.	Baseline and Week 12
Secondary	Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12	Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per CDAI at Week 12, assessed for participants taking corticosteroids for CD at Baseline.; CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.	Week 12
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12	The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.	Baseline and Week 12
Secondary	Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12	The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.	Baseline and Week 12
Secondary	Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2	Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.; CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.	Baseline and Week 2
Secondary	Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12	Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.; CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.	Baseline and Week 12
Secondary	Percentage of Participants With Clinical Remission Per CDAI at Week 4	CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.	Week 4
Secondary	Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period	This was assessed by reviewing participant's hospitalization data.	12 weeks
Secondary	Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12	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.; Only participants with any EIM present at Baseline were included in the analysis of resolution of EIMs. Resolution of EIMs was defined as absence of all EIMs at the Week 12 visit.	Week 12
Secondary	Percentage of Participants With Clinical Remission Per PROs at Week 4	Clinical remission per PROs was defined as average daily very soft or liquid SF = 2.8 and average daily APS = 1.0 and neither worse than Baseline.; Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).; The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 4 visit.	Week 4
Secondary	Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12	Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per PROs at Week 12, assessed for participants taking corticosteroids for CD at Baseline.; Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) = 2.8 and average daily APS = 1.0 and neither worse than Baseline.; Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).; The average daily liquid or very soft SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.	Week 12

External Links

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