A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Crohn's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104413
• Other study ID #: M15-991
• Secondary ID: 2016-003190-17
• Status: Completed
• Phase: Phase 3
• Start date: December 18, 2017
• Est. completion date: May 19, 2021

Study information

• Verified date: August 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: May 19, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

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

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

• Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

• Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).

• Demonstrated intolerance or inadequate response to biologic therapy for CD.

• If female, participant must meet the contraception recommendations.

Exclusion Criteria:

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

• Participants with unstable doses of concomitant Crohn's disease therapy.

• Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.

• Prior exposure to p19 inhibitors (e.g., risankizumab).

• Complications of Crohn's disease.

• Having an ostomy or ileoanal pouch.

• Known active Coronavirus Disease 2019 (COVID-19) infection.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.
• risankizumab SC
risankizumab administered by subcutaneous (SC) injection
• risankizumab IV
risankizumab administered as intravenous (IV) infusion.

Locations

Country	Name	City	State
Argentina	Cemic /Id# 168082	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 168081	Ciudad Autonoma de Buenos Aire	Ciuadad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 168080	Cordoba
Argentina	Hospital Provincial del Centenario /ID# 170904	Rosario	Santa Fe
Australia	Emeritus Research /ID# 213510	Camberwell	Victoria
Australia	Lyell McEwin Hospital /ID# 211364	Elizabeth Vale	South Australia
Australia	Footscray Hospital /ID# 211362	Footscray	Victoria
Australia	Mater Misericordiae Limited /ID# 167216	South Brisbane	Queensland
Australia	Griffith University /ID# 212631	Southport	Queensland
Austria	Duplicate_LKH-Univ. Klinikum Graz /ID# 158134	Graz	Steiermark
Austria	Universitaetsklinikum St. Poelten /ID# 166423	Sankt Poelten	Niederoesterreich
Austria	Duplicate_Medical University of Vienna /ID# 158135	Vienna	Wien
Austria	Krankenhaus der Barmherzigen Brueder Wien /ID# 211418	Vienna	Wien
Belarus	Vitebsk Regional Advanced Clin /ID# 204807	???????
Belgium	Imelda Ziekenhuis /ID# 157381	Bonheiden
Belgium	ULB Hospital Erasme /ID# 157386	Brussels	Bruxelles-Capitale
Belgium	AZ Maria Middelares /ID# 212871	Gent
Belgium	UZ Gent /ID# 157383	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge /ID# 212571	Kortrijk
Belgium	AZ Sint-Maarten /ID# 212280	Mechelen	Antwerpen
Belgium	ZNA - Jan Palfijn /ID# 212822	Merksem
Belgium	UCL Saint-Luc /ID# 157384	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 157710	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 165018	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 165132	Sarajevo
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 203975	Pleven
Bulgaria	University Multiprofile Hospit /ID# 165697	Plovdiv
Bulgaria	Acibadem City Clinic UMHAT Tokuda /ID# 165698	Sofia
Bulgaria	Second Multiprofile Hospital f /ID# 165699	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 204713	Sofia
Bulgaria	UMHAT Tsaritsa Joanna - ISUL /ID# 211241	Sofia
Bulgaria	MHAT Trakia /ID# 201665	Stara Zagora
Bulgaria	University Multiprofile Hospit /ID# 167576	Varna
Canada	University of Calgary - Heritage Medical Research Clinic /ID# 157156	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 169766	Edmonton	Alberta
Canada	Covenant Health /ID# 161636	Edmonton	Alberta
Canada	University of Alberta - Zeidler Ledcor Centre /ID# 157100	Edmonton	Alberta
Canada	CISSS de la Monteregie /ID# 161634	Greenfield Park	Quebec
Canada	IWK Health Center /ID# 165909	Halifax	Nova Scotia
Canada	QEII - Health Sciences Centre /ID# 157089	Halifax	Nova Scotia
Canada	London Health Sciences Center /ID# 157162	London	Ontario
Canada	CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070	Montreal	Quebec
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Center /ID# 157086	Montreal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 159057	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 165910	North Bay	Ontario
Canada	Medicor Research Inc /ID# 157151	Sudbury	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 157097	Vancouver	British Columbia
Canada	Toronto Digestive Disease Asso /ID# 157159	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 161635	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 210758	Concepción
Chile	Complejo Asistencial Dr. Sotero del Rio /ID# 169383	Santiago	Region Metropolitana De Santiago
Chile	Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121	Santiago	Region Metropolitana De Santiago
Chile	Hospital Las Higueras /ID# 167091	Talcahuano
Chile	Centro de Investigaciones Clínicas Viña del Mar /ID# 203585	Viña del Mar	Valparaíso
China	West China Hospital, Sichuan University /ID# 210888	Chengdu
China	The Sixth Affiliated Hosp Sun /ID# 210783	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 211035	Nanchang	Jiangxi
China	Shanghai East Hospital /ID# 212671	Pudong New District
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210706	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842	Shanghai	Shanghai
China	Duplicate_Tianjin Med Univ General Hosp /ID# 210925	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211040	Wuhan	Hubei
Colombia	Hospital Univ San Ignacio /ID# 158737	Bogota	Cundinamarca
Colombia	Instituto de Coloproctologia /ID# 158740	Medellin	Antioquia
Colombia	Hospital Pablo Tobon Uribe /ID# 158732	Medellín	Antioquia
Croatia	UHC Osijek /ID# 157704	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 157705	Split	Splitsko-dalmatinska Zupanija
Croatia	Zadar General Hospital /ID# 157706	Zadar
Croatia	Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 157720	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 157703	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 163218	Hradec Kralove
Czechia	CTCenter MaVe s.r.o. /ID# 163215	Olomouc
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 163219	Pardubice
Czechia	Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165479	Prague 4	Praha 4
Czechia	Axon Clinical, s.r.o. /ID# 163216	Praha
Czechia	Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304	Praha
Czechia	NH Hospital a.s. /ID# 211073	Praha
Czechia	ResTrial s.r.o. /ID# 211074	Praha
Czechia	Thomayerova nemocnice /ID# 162942	Praha
Denmark	Aalborg Universitets Hospital /ID# 160685	Aalborg
Denmark	Aarhus University Hospital /ID# 155534	Aarhus N	Midtjylland
Denmark	Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535	Hvidovre	Hovedstaden
Denmark	Sygehusenheden Nyborg - OUH /ID# 161591	Nyborg	Syddanmark
Denmark	Odense Universitets Hospital /ID# 155536	Odense C
Denmark	Sjællands Universitetshospital, Roskilde /ID# 155537	Roskilde	Sjælland
Egypt	Zagazig University Hospitals /ID# 164018	Al Sharqia
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423	Alexandria
Egypt	Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157176	Cairo
Egypt	Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630	Cairo
Egypt	National Hepatology and Tropical Medicine Research Institute /ID# 157875	Cairo
Estonia	East Tallinn Central Hospital /ID# 157072	Tallinn	Harjumaa
Estonia	West Tallinn Central Hospital /ID# 157073	Tallinn
France	CHU Amiens-Picardie Site Sud /ID# 165056	Amiens CEDEX 1	Somme
France	Hapital Beaujon /ID# 166287	Clichy	Ile-de-France
France	CHU Grenoble - Hopital Michallon /ID# 211980	La Tronche
France	CHRU Lille - Hopital Claude Huriez /ID# 162547	Lille	Hauts-de-France
France	CHU Montpellier - Hôpital Saint Eloi /ID# 215146	Montpellier Cedex 5	Herault
France	Chu de Nice-Hopital L'Archet Ii /Id# 162545	Nice	Alpes-Maritimes
France	CHU Bordeaux - Hopital Haut Lévêque /ID# 162546	Pessac CEDEX	Gironde
France	HCL - Hôpital Lyon Sud /ID# 162548	Pierre Benite CEDEX	Auvergne-Rhone-Alpes
France	Hospital Pontchaillou /ID# 213207	Rennes
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 162550	St. Priest En Jarez	Loire
France	CHRU Nancy - Hôpitaux de Brabois /ID# 162549	Vandœuvre-lès-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218	Berlin
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212892	Berlin
Germany	DRK Kliniken Berlin Westend /ID# 166149	Berlin
Germany	Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211976	Berlin
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339	Berlin
Germany	Krankenhaus Waldfriede /ID# 212729	Berlin-Zehlendorf
Germany	Stadtisches Klinikum Braunschweig /ID# 163673	Braunschweig
Germany	Evangelisches Krankenhaus Kalk /ID# 212724	Cologne	Nordrhein-Westfalen
Germany	Medizinisches Versorgunszentrum Dachau /ID# 211550	Dachau
Germany	Universitaetsklinikum Erlangen /ID# 159332	Erlangen	Bayern
Germany	Agaplesion Markus Krankenhaus /ID# 159334	Frankfurt am Main
Germany	Universitaetsklinikum Frankfurt /ID# 212977	Frankfurt am Main	Hessen
Germany	Duplicate_Universitaetsklinikum Freiburg /ID# 162025	Freiburg
Germany	Praxiszentrum fuer Gastroenterologie /ID# 211965	Grevenbroich	Nordrhein-Westfalen
Germany	Asklepios Westklinikum Hamburg /ID# 159336	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 162027	Hannover
Germany	Praxis fuer Gastroenterologie /ID# 166148	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Koeln /ID# 164987	Köln	Nordrhein-Westfalen
Germany	EUGASTRO GmbH /ID# 212077	Leipzig
Germany	Klinikum Lueneburg /ID# 163671	Lueneburg
Germany	Universitaetsklinikum Magdeburg /ID# 211840	Magdeburg
Germany	Universitatsklinikum Mannheim /ID# 162026	Mannheim	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024	Minden
Germany	Universitaetsklinikum Muenster /ID# 159333	Muenster	Nordrhein-Westfalen
Germany	Universitaetsklinikum Regensburg /ID# 163812	Regensburg
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527	Saarbrücken	Saarland
Germany	Universitaetsklinikum Tuebingen /ID# 159341	Tübingen	Baden-Wuerttemberg
Germany	Universitaetsklinikum Ulm /ID# 164988	Ulm	Baden-Wuerttemberg
Germany	Duplicate_Gastro-Praxis Wiesbaden /ID# 159335	Wiesbaden
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418	Athens
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 157417	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 157415	Ioannina
Greece	Tzaneio general hospital of Piraeus /ID# 206441	Piraeus	Attiki
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419	Pireaus
Greece	Theageneio Anticancer Hospital /ID# 163922	Thessaloniki
Ireland	Beaumont Hospital /ID# 157572	Beaumont	Dublin
Ireland	St Vincent's University Hospital /ID# 157569	Elm Park	Dublin
Ireland	University Hospital Galway /ID# 157570	Galway
Israel	Soroka University Medical Center /ID# 157789	Be'er Sheva	HaDarom
Israel	Duplicate_Rambam Medical Center /ID# 171056	Haifa
Israel	Hadassah Medical Center-Hebrew University /ID# 171062	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 163539	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 171055	Jerusalem
Israel	Sheba Medical Center /ID# 171059	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 157787	Tel Aviv-Yafo	Tel-Aviv
Italy	A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659	Bologna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 161303	Catania
Italy	Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017	Catanzaro	Calabria
Italy	Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168049	Florence	Toscana
Italy	Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434	Genoa	Liguria
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155657	Milan
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155655	Milano
Italy	Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018	Modena	Emilia-Romagna
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302	Negrar	Verona
Italy	Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212030	Pavia
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211453	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 155660	Rome	Lazio
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910	Rome	Lazio
Italy	Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433	Rome	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 158023	Rome	Roma
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 155658	Rozzano	Milano
Italy	Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431	Torrette	Ancona
Korea, Republic of	Duplicate_Dong-A University Hospital /ID# 163370	Busan
Korea, Republic of	Inje University Haeundae Hospital /ID# 202516	Busan
Korea, Republic of	Pusan National University Hospital /ID# 163376	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 163366	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553	Daejeon
Korea, Republic of	Hanyang University Guri Hospital /ID# 163351	Guri	Gyeonggido
Korea, Republic of	CHA Bundang Medical center CHA University /ID# 163377	Seongnam si	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 163354	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 163426	Seoul
Korea, Republic of	Severance Hospital /ID# 163374	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital /ID# 163365	Suwon	Gyeonggido
Latvia	Pauls Stradins Clinical University Hospital /ID# 159616	Riga
Latvia	Riga East Clinical University Hospital /ID# 159615	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584	Kaunas
Lithuania	Vinius University Hospital Santaros Klinikos /ID# 162524	Vilnius
Malaysia	Queen Elizabeth Hospital /ID# 160659	Division Pantai Barat Utara	Sabah
Malaysia	Universiti Sains Malaysia /ID# 160661	Kelantan
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362	Kuala Lumpur	Selangor
Mexico	JM Research SC /ID# 170762	Cuernavaca	Morelos
Mexico	Health Pharma Professional Research S.A de C.V /ID# 170763	Del. Benito Juárez
Mexico	Unidad de Atencion Medica e Investigacion en Salud /ID# 170765	Merida	Yucatan
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766	Zapopan	Jalisco
Netherlands	Academisch Medisch Centrum /ID# 157953	Amsterdam
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 163620	Tilburg
New Zealand	Middlemore Clinical Trials /ID# 167214	Auckland
New Zealand	Christchurch Hospital /ID# 167212	Christchurch	Canterbury
New Zealand	Dunedin Hospital /ID# 167215	Dunedin	Otago
New Zealand	Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213	Wellington
Poland	Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079	Chojnice	Pomorskie
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212290	Lodz	Lodzkie
Poland	1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984	Lublin	Lubelskie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980	Lublin	Lubelskie
Poland	Wojewodzki Szpital Specjalistyczny /ID# 212400	Olsztyn	Warminsko-mazurskie
Poland	Centrum Medyczne Medyk /ID# 212888	Rzeszów	Podkarpackie
Poland	H-T. Centrum Medyczne - Endoterapia /ID# 212458	Tychy	Slaskie
Poland	Duplicate_Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434	Warsaw
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 163602	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578	Warszawa	Mazowieckie
Poland	Planetmed Sp. z o.o. /ID# 205159	Wroclaw	Dolnoslaskie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534	Wroclaw
Portugal	Hospital Garcia de Orta, EPE /ID# 160688	Almada
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732	Faro
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691	Guimaraes	Braga
Portugal	Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167753	Lisboa
Portugal	Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160741	Lisboa
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677	Lisboa
Portugal	Hospital Beatriz Ângelo /ID# 207758	Loures
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754	Portimão	Faro
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 160676	Santa Maria Da Feira	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 160731	Viseu
Romania	Duplicate_Institutul Clinic Fundeni /ID# 170888	Bucharest
Romania	Tvm Med Serv Srl /Id# 170891	Cluj
Romania	Institutul Clinic Fundeni /ID# 170890	Sector 2	Bucuresti
Romania	Cabinet Particular Policlinic Algomed /ID# 170889	Timi?oara
Romania	Duplicate_Centrul Medical Tuculanu SRL /ID# 170892	Timisoara
Russian Federation	Alliance Biomedical Ural Group /ID# 200703	Izhevsk	Udmurtskaya Respublika
Russian Federation	Kuzbass Regional Clinical Hospital /ID# 200707	Kemerovo	Kemerovskaya Oblast
Russian Federation	National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806	Moscow
Russian Federation	Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438	Perm	Permskiy Kray
Russian Federation	City Clinical Hospital No. 31 /ID# 208865	St. Petersburg
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200701	Stavropol	Stavropol Skiy Kray
Russian Federation	Tver Regional Clinical Hospital /ID# 206586	Tver	Tverskaya Oblast
Russian Federation	Regional Clinical Hospital #1 /ID# 200708	Tyumen	Tyumenskaya Oblast
Russian Federation	Ulyanovsk Regional Clinical Hospital /ID# 200700	Ulyanovsk
Serbia	Clinical Hosp Center Zvezdara /ID# 156956	Belgrade	Beograd
Serbia	Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798	Belgrade
Serbia	Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 156963	Belgrade	Beograd
Serbia	University Children's Hospital 'Tirsova' /ID# 211480	Belgrade
Serbia	University Clinical Center Serbia /ID# 156957	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 156961	Kragujevac	Sumadijski Okrug
Serbia	Clinical Center Vojvodina /ID# 156958	Novi Sad	Vojvodina
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 205736	Singapore
Singapore	National University Hospital /ID# 160662	Singapore
Singapore	Singapore General Hospital /ID# 160663	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156453	Banska Bystrica
Slovakia	Univerzitna nemocnica Martin /ID# 163205	Martin
Slovakia	KM Management, spol. s.r.o. /ID# 206762	Nitra
Slovakia	GASTRO I., s.r.o. /ID# 156455	Presov
South Africa	Kingsbury Hospital /ID# 171158	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 171159	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 171172	CAPE TOWN Milnerton	Western Cape
South Africa	Wits Clinical Research Site /ID# 171169	Johannesburg	Gauteng
Spain	Hospital Clinic de Barcelona /ID# 157533	Barcelona
Spain	Hospital Universitario Basurto /ID# 205188	Bilbao	Vizcaya
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534	Ferrol	A Coruna
Spain	Hospital General Universitario Gregorio Maranon /ID# 161144	Madrid
Spain	Hospital Universitario La Paz /ID# 159232	Madrid
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Salamanca /ID# 157539	Salamanca
Spain	Hospital Universitario Virgen Macarena /ID# 159966	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 209699	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 157537	Valencia
Spain	Hospital Universitario Miguel Servet /ID# 157538	Zaragoza
Switzerland	Universitätsspital Basel /ID# 166321	Basel	Basel-Stadt
Switzerland	Universitätsspital Zürich /ID# 163528	Zürich	Zuerich
Taiwan	Taichung Veterans General Hosp /ID# 160134	Taichung
Taiwan	China Medical University Hosp /ID# 160130	Taichung City
Taiwan	National Cheng Kung University Hospital /ID# 160129	Tainan City
Taiwan	National Taiwan University Hospital /ID# 162189	Taipei City
Taiwan	Taipei Veterans General Hosp /ID# 212711	Taipei City
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 162527	????
Ukraine	Duplicate_Transcarpathian Regional Clin. /ID# 167958	Uzhhorod
United Kingdom	Barnsley Hospital NHS Foundation Trust /ID# 202772	Barnsley
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 157577	Birmingham
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 158037	Cambridge
United Kingdom	Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938	Chertsey	Surrey
United Kingdom	NHS Lothian /ID# 207446	Edinburgh
United Kingdom	NHS Greater Glasgow and Clyde /ID# 202314	Glasgow	Scotland
United Kingdom	Hull University Teaching Hospitals NHS Trust /ID# 158759	Hull
United Kingdom	King's College Hospital NHS Foundation Trusts /ID# 158758	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889	Newcastle Upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 158039	Oxford
United Kingdom	Duplicate_Northern Care Alliance NHS Group /ID# 207765	Salford
United States	TX Clinical Research Institute /ID# 159396	Arlington	Texas
United States	Atlanta Gastro Assoc /ID# 154755	Atlanta	Georgia
United States	Gastroenterology Associates LLC - Jefferson Hwy /ID# 161970	Baton Rouge	Louisiana
United States	Inquest Clinical Research /ID# 165696	Baytown	Texas
United States	Washington Gastroenterology Associates /ID# 162101	Bellevue	Washington
United States	HP Clinical Research /ID# 162992	Bountiful	Utah
United States	Seffner Premier Health Care, PA /ID# 162259	Brandon	Florida
United States	NY Scientific /ID# 158272	Brooklyn	New York
United States	Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446	Burnt Hills	New York
United States	Texas Digestive Disease Consultants /ID# 209781	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209945	Cedar Park	Texas
United States	Medical University of South Carolina /ID# 212859	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 158364	Charlotte	North Carolina
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846	Chevy Chase	Maryland
United States	Northwestern University Division of GI/Hepatology /ID# 158250	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 157113	Chicago	Illinois
United States	Tri-State Endoscopy /ID# 154939	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc /ID# 205864	Clearwater	Florida
United States	Clinical Research of West Florida, Inc /ID# 208127	Clearwater	Florida
United States	South Lake Pain Institute, Inc /ID# 162798	Clermont	Florida
United States	Cleveland Clinic Main Campus /ID# 209225	Cleveland	Ohio
United States	Peak Gastroenterology Associates, PC /ID# 165832	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 164766	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 167877	Columbus	Ohio
United States	The Ohio State University /ID# 164706	Columbus	Ohio
United States	Southern California Res. Ctr. /ID# 211989	Coronado	California
United States	Western Connecticut Medical Group /ID# 165874	Danbury	Connecticut
United States	Hometown Urgent Care and Resea /ID# 170447	Dayton	Ohio
United States	Omega Research Maitland, LLC /ID# 171080	DeBary	Florida
United States	Universal Axon Clinical Research /ID# 165426	Doral	Florida
United States	NorthShore University HealthSystem /ID# 158254	Evanston	Illinois
United States	Plains Clinical Research Center, LLC /ID# 169712	Fargo	North Dakota
United States	Intercity Advanced Gastroentertology Center /ID# 215204	Fresh Meadows	New York
United States	DHAT Research Institute /ID# 158199	Garland	Texas
United States	Gastro One /ID# 154757	Germantown	Tennessee
United States	Duplicate_Long Island Clinical Research /ID# 154843	Great Neck	New York
United States	Gastroenterology Associates, P.A. of Greenville /ID# 154919	Greenville	South Carolina
United States	PennState Milton S.Hershey Med /ID# 154894	Hershey	Pennsylvania
United States	Houma Digestive Health Special /ID# 158253	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 158194	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 201218	Houston	Texas
United States	CliniCore International, LLC /ID# 158191	Houston	Texas
United States	Precision Research Institute, LLC /ID# 201072	Houston	Texas
United States	Vilo Research Group Inc /ID# 207654	Houston	Texas
United States	Newport Huntington Medica /ID# 213034	Huntington Beach	California
United States	East Tennessee Research Institute /ID# 168735	Johnson City	Tennessee
United States	Vidant Multispecialty Clinic - Kinston /ID# 161109	Kinston	North Carolina
United States	SIH Research Mumtaz, Inc /ID# 163081	Kissimmee	Florida
United States	UC San Diego Health Systems /ID# 155576	La Jolla	California
United States	Las Vegas Medical Research /ID# 160167	Las Vegas	Nevada
United States	Revival Research Institute, Inc /ID# 210986	Las Vegas	Nevada
United States	University of Kentucky Chandler Medical Center /ID# 157109	Lexington	Kentucky
United States	Alliance Medical Research /ID# 163834	Lighthouse Point	Florida
United States	Duplicate_Atria Clinical Research /ID# 164504	Little Rock	Arkansas
United States	Rocky Mountain Pediatric Gastroenterology /ID# 207171	Lone Tree	Colorado
United States	United Medical Doctors /ID# 207887	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655	Los Angeles	California
United States	TLC Clinical Research Inc /ID# 212501	Los Angeles	California
United States	University of Louisville /ID# 210523	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 154865	Macon	Georgia
United States	Cfagi Llc /Id# 202482	Maitland	Florida
United States	Duplicate_Clinical Neuroscience Solutions, Inc /ID# 164179	Memphis	Tennessee
United States	Great Lakes Medical Research, LLC /ID# 201774	Mentor	Ohio
United States	Coral Research Clinic /ID# 158330	Miami	Florida
United States	ITB Research /ID# 161278	Miami	Florida
United States	South Florida Research Ph I-IV, Inc. /ID# 161825	Miami	Florida
United States	University of Miami /ID# 155011	Miami	Florida
United States	Vista Health Research, LLC /ID# 212828	Miami	Florida
United States	WVU Medicine /ID# 167942	Morgantown	West Virginia
United States	United Medical Doctors - Murrieta /ID# 158278	Murrieta	California
United States	Gastroenterology Group Naples /ID# 165192	Naples	Florida
United States	Vanderbilt University Medical Center /ID# 157110	Nashville	Tennessee
United States	Digestive Disease Care /ID# 211776	New Hyde Park	New York
United States	North Shore University Hospital /ID# 168734	New Hyde Park	New York
United States	Delricht Research /ID# 206567	New Orleans	Louisiana
United States	Nola Research Works, LLC /ID# 161271	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 161973	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 167545	New York	New York
United States	Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610	New York	New York
United States	Lenox Hill Hospital /ID# 168466	New York	New York
United States	NYU Langone Medical Center /ID# 160166	New York	New York
United States	Weill Cornell Medicine /ID# 165856	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 171130	North Massapequa	New York
United States	Southwest Gastroenterology /ID# 164764	Oak Lawn	Illinois
United States	Advanced Research Institute /ID# 154922	Ogden	Utah
United States	Digestive Disease Specialists /ID# 170772	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 211992	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center /ID# 210056	Omaha	Nebraska
United States	Endoscopic Research, Inc. /ID# 205903	Orlando	Florida
United States	IMIC Inc. Medical Research /ID# 154944	Palmetto Bay	Florida
United States	Phoenix VA Health Care System /ID# 162261	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh of UPMC /ID# 212543	Pittsburgh	Pennsylvania
United States	Northwest Gastroenterology Clinic /ID# 158255	Portland	Oregon
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891	Raleigh	North Carolina
United States	Rapid City Medical Center - GI Research /ID# 163835	Rapid City	South Dakota
United States	Hunter Holmes McGuire VA Medical Center /ID# 159977	Richmond	Virginia
United States	Mayo Clinic - Rochester /ID# 163084	Rochester	Minnesota
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 161307	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 168772	San Antonio	Texas
United States	HonorHealth Research Institute - Shea /ID# 165825	Scottsdale	Arizona
United States	Virginia Mason - Seattle Orthapedics /ID# 155577	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 162239	Shreveport	Louisiana
United States	Clinical Research Trials of Florida, Inc. /ID# 201606	Tampa	Florida
United States	Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882	Tempe	Arizona
United States	Baylor Scott & White Medical Center- Temple /ID# 204129	Temple	Texas
United States	Cotton-O'Neil Clinical Res Ctr /ID# 154753	Topeka	Kansas
United States	Center for Digestive Health /ID# 154697	Troy	Michigan
United States	University of Arizona /ID# 158305	Tucson	Arizona
United States	Adult Gastroenterology Associates - Gen 1 Research /ID# 208857	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 166795	Tyler	Texas
United States	Gastro Health & Nutrition - Victoria /ID# 164284	Victoria	Texas
United States	Velocity Clinical Research - Salt Lake City /ID# 161775	West Jordan	Utah
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267	Wyoming	Michigan
United States	Digestive Disease Associates, LTD /ID# 208296	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Egypt,  Estonia,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission	The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.	Week 12
Primary	US Specific: Percentage of Participants With Endoscopic Response	The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).	Week 12
Primary	Global Outside of US: Percentage of Participants With Clinical Remission	Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.	Week 12
Primary	Global Outside of US: Percentage of Participants With Endoscopic Response	The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).	Week 12
Secondary	US Specific: Percentage of Participants With Clinical Remission	Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.	Week 12
Secondary	US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.	Week 4
Secondary	US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.	Week 12
Secondary	US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue	The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.	Week 12
Secondary	US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.	Week 4
Secondary	US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.; Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).	Week 12
Secondary	US Specific: Percentage of Participants With Stool Frequency (SF) Remission	Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.	Week 12
Secondary	US Specific: Percentage of Participants With Abdominal Pain (AP) Remission	The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.	Week 12
Secondary	US Specific: Percentage of Participants With Endoscopic Remission	Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable	Week 12
Secondary	US Specific: Percentage of Participants With Enhanced Clinical Response	Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission	Week 4
Secondary	US Specific: Percentage of Participants With Ulcer-Free Endoscopy	Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore = 1 at Baseline	Week 12
Secondary	US Specific: Percentage of Participants With Enhanced Clinical Response	Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission	Week 12
Secondary	US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline	Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.	Week 12
Secondary	US Specific: Percentage of Participants With CD-Related Hospitalization	Participants with at least one admission to the hospital due to Crohn's Disease.	Up to Week 12
Secondary	US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline	Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.	Week 12
Secondary	Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission	The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.	Week 12
Secondary	Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.	Week 4
Secondary	Global Outside of US: Percentage of Participants With Clinical Remission	Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.	Week 4
Secondary	Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response	Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.	Week 12
Secondary	Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue	The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.	Week 12
Secondary	Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score	The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.	Week 12
Secondary	Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response	Enhanced clinical response was defined as = 60% decrease in average daily Stool Frequency and/or = 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).	Week 12
Secondary	Global Outside of US:: Percentage of Participants With Endoscopic Remission	Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable	Week 12
Secondary	Global Outside of US: Percentage of Participants With Enhanced Clinical Response	Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission	Week 4
Secondary	Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy	Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore = 1 at Baseline	Week 12
Secondary	Global Outside of US: Percentage of Participants With Enhanced Clinical Response	Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission	Week 12
Secondary	Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline	Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.	Week 12
Secondary	Global Outside of US: Percentage of Participants With CD-Related Hospitalization	Participants with at least one admission to the hospital due to Crohn's Disease.	Week 12
Secondary	Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline	Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.	Week 12
Secondary	Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment	WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Week 12
Secondary	Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score	The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.	Week 12

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