A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105128
• Other study ID #: M16-006
• Secondary ID: 2016-003123-32
• Status: Completed
• Phase: Phase 3
• Start date: May 10, 2017
• Est. completion date: April 14, 2021

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 931
• Est. completion date: April 14, 2021
• Est. primary completion date: November 9, 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.
• 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, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
• Demonstrated intolerance or inadequate response to conventional or 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 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
Placebo for risankizumab administered by intravenous infusion
• risankizumab IV
Risankizumab administered by intravenous infusion
• risankizumab SC
Risankizumab administered by subcutaneous (SC) injection

Locations

Country	Name	City	State
Argentina	Hospital Privado Univesitario /ID# 161988	Cordoba
Argentina	Duplicate_HOSPITAL CENTENARIO /ID# 170883	Rosario	Santa Fe
Australia	Emeritus Research /ID# 213511	Camberwell	Victoria
Australia	Lyell McEwin Hospital /ID# 211363	Elizabeth Vale	South Australia
Australia	Footscray Hospital /ID# 211361	Footscray	Victoria
Australia	Duplicate_Mater Hospital /ID# 167990	South Brisbane	Queensland
Australia	Griffith University /ID# 212627	Southport	Queensland
Austria	Medizinische Universitaet Graz /ID# 158137	Graz	Steiermark
Austria	Universitaetsklinikum St. Poelten /ID# 166425	Sankt Poelten	Niederoesterreich
Austria	Duplicate_Medical University of Vienna /ID# 158138	Vienna	Wien
Austria	Krankenhaus der Barmherzigen Brueder Wien /ID# 212059	Vienna	Wien
Belarus	Vitebsk Regional Advanced Clin /ID# 159497	???????
Belarus	Gomel Regional Clinical Hospital /ID# 159498	Gomel
Belarus	Grodno city clinical hospital #2 /ID# 159499	Grodno
Belgium	Imelda Ziekenhuis /ID# 157392	Bonheiden
Belgium	ULB Hospital Erasme /ID# 157397	Brussels	Bruxelles-Capitale
Belgium	UZ Gent /ID# 157394	Gent	Oost-Vlaanderen
Belgium	CHU UCL Namur - site Godinne /ID# 157401	Godinne	Namur
Belgium	Universitair Ziekenhuis Leuven /ID# 157396	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 157398	Liege
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 157393	Liege
Belgium	AZ-Delta /ID# 157391	Roeselare
Belgium	UCL Saint-Luc /ID# 157395	Woluwe-Saint-Lambert	Bruxelles-Capitale
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 157717	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska /ID# 164512	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 165134	Sarajevo
Brazil	Upeclin Fmb - Unesp /Id# 157688	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 157646	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157672	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 157653	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157649	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 159672	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 157656	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 203977	Pleven
Bulgaria	University Multiprofile Hospit /ID# 158644	Plovdiv
Bulgaria	Duplicate_Tokuda Hospital Sofia /ID# 158645	Sofia
Bulgaria	Second Multiprofile Hospital f /ID# 158646	Sofia
Bulgaria	UMHAT Sveti Ivan Rilski /ID# 204714	Sofia
Bulgaria	UMHAT Tsaritsa Joanna - ISUL /ID# 211240	Sofia
Bulgaria	MHAT Trakia /ID# 201672	Stara Zagora
Bulgaria	University Multiprofile Hospit /ID# 167575	Varna
Canada	University of Calgary - Heritage Medical Research Clinic /ID# 157152	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 169761	Edmonton	Alberta
Canada	Covenant Health /ID# 161617	Edmonton	Alberta
Canada	University of Alberta - Zeidler Ledcor Centre /ID# 157098	Edmonton	Alberta
Canada	CISSS de la Monteregie /ID# 161615	Greenfield Park	Quebec
Canada	IWK Health Center /ID# 165900	Halifax	Nova Scotia
Canada	QEII - Health Sciences Centre /ID# 157087	Halifax	Nova Scotia
Canada	CHAU- Hotel-Dieu de Levis /ID# 214375	Levis	Quebec
Canada	London Health Sciences Center /ID# 157160	London	Ontario
Canada	CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167066	Montreal	Quebec
Canada	CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159054	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Center /ID# 157084	Montreal	Quebec
Canada	Fraser Clinical Trials Inc /ID# 159053	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 165903	North Bay	Ontario
Canada	Medicor Research Inc /ID# 157149	Sudbury	Ontario
Canada	Mount Sinai Hospital /ID# 169762	Toronto	Ontario
Canada	GIRI Gastrointestinal Research Institute /ID# 157095	Vancouver	British Columbia
Canada	Toronto Digestive Disease Asso /ID# 157157	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 161616	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 210759	Concepción
Chile	Complejo Asistencial Dr. Sotero del Rio /ID# 169382	Santiago	Region Metropolitana De Santiago
Chile	Hospital Las Higueras /ID# 167090	Talcahuano
Chile	Centro de Investigaciones Clínicas Viña del Mar /ID# 203589	Viña del Mar	Valparaíso
China	The Second Hospital Central South University /ID# 211696	Changsha
China	West China Hospital, Sichuan University /ID# 210889	Chengdu
China	Guangdong Provincial People's Hospital /ID# 212948	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 210785	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210624	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210725	Hangzhou	Zhejiang
China	Jinhua Municipal Central Hospital /ID# 215626	Jinhua	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 211034	Nanchang	Jiangxi
China	Shanghai East Hospital /ID# 212683	Pudong New District
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210707	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210841	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University /ID# 212740	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital /ID# 210927	Tianjin
China	Renmin Hospital of Wuhan University /ID# 214873	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210856	Wuhan	Hubei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211038	Wuhan	Hubei
Colombia	Hospital Univ San Ignacio /ID# 158733	Bogota	Cundinamarca
Colombia	Hospital Universitario San Vic /ID# 171487	Medellin
Colombia	Instituto de Coloproctologia /ID# 158741	Medellin	Antioquia
Colombia	Hospital Pablo Tobon Uribe /ID# 158735	Medellín	Antioquia
Croatia	UHC Osijek /ID# 157564	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Split /ID# 157567	Split	Splitsko-dalmatinska Zupanija
Croatia	Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157565	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 157721	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 157566	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 163134	Hradec Kralove
Czechia	CTCenter MaVe s.r.o. /ID# 163149	Olomouc
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 163182	Pardubice
Czechia	Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165463	Prague 4	Praha 4
Czechia	Axon Clinical, s.r.o. /ID# 163176	Praha
Czechia	Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211305	Praha
Czechia	NH Hospital a.s. /ID# 211076	Praha
Czechia	ResTrial s.r.o. /ID# 211075	Praha
Czechia	Thomayerova nemocnice /ID# 162940	Praha
Estonia	East Tallinn Central Hospital /ID# 157076	Tallinn	Harjumaa
Estonia	North Estonia Medical Centre /ID# 163507	Tallinn
Estonia	West Tallinn Central Hospital /ID# 157077	Tallinn
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212219	Berlin
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212893	Berlin
Germany	DRK Kliniken Berlin Westend /ID# 166146	Berlin
Germany	Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211972	Berlin
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159322	Berlin
Germany	Krankenhaus Waldfriede /ID# 212728	Berlin-Zehlendorf
Germany	Stadtisches Klinikum Braunschweig /ID# 163666	Braunschweig
Germany	Evangelisches Krankenhaus Kalk /ID# 212725	Cologne	Nordrhein-Westfalen
Germany	Medizinisches Versorgunszentrum Dachau /ID# 211557	Dachau
Germany	Universitaetsklinikum Erlangen /ID# 159315	Erlangen	Bayern
Germany	Agaplesion Markus Krankenhaus /ID# 159317	Frankfurt am Main
Germany	Universitaetsklinikum Frankfurt /ID# 212978	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Freiburg /ID# 162019	Freiburg	Baden-Wuerttemberg
Germany	Praxiszentrum fuer Gastroenterologie /ID# 211964	Grevenbroich	Nordrhein-Westfalen
Germany	Asklepios Westklinikum Hamburg /ID# 159319	Hamburg
Germany	Medizinische Hochschule Hannover /ID# 162021	Hannover
Germany	Praxis fuer Gastroenterologie /ID# 166145	Heidelberg	Baden-Wuerttemberg
Germany	Universitaetsklinikum Jena /ID# 159323	Jena	Thueringen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159321	Kiel	Schleswig-Holstein
Germany	Universitaetsklinikum Koeln /ID# 164985	Köln	Nordrhein-Westfalen
Germany	EUGASTRO GmbH /ID# 212076	Leipzig
Germany	Klinikum Lueneburg /ID# 163664	Lueneburg
Germany	Universitaetsklinikum Magdeburg /ID# 211847	Magdeburg
Germany	Universitatsklinikum Mannheim /ID# 162020	Mannheim	Baden-Wuerttemberg
Germany	Gastroenterologische Gemeinschaftspraxis Minden /ID# 162018	Minden
Germany	Universitaetsklinikum Muenster /ID# 159316	Muenster	Nordrhein-Westfalen
Germany	Universitaetsklinikum Regensburg /ID# 163665	Regensburg
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210529	Saarbrücken	Saarland
Germany	Universitaetsklinikum Tuebingen /ID# 159324	Tübingen	Baden-Wuerttemberg
Germany	Universitaetsklinikum Ulm /ID# 164986	Ulm	Baden-Wuerttemberg
Germany	Duplicate_Gastro-Praxis Wiesbaden /ID# 159318	Wiesbaden
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157428	Athens
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 171077	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 157427	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 157425	Ioannina
Greece	Tzaneio general hospital of Piraeus /ID# 206445	Piraeus	Attiki
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157429	Pireaus
Greece	Theageneio Anticancer Hospital /ID# 163921	Thessaloniki
Hong Kong	Queen Mary Hospital /ID# 163902	Hong Kong
Hong Kong	Tuen Mun Hospital /ID# 163901	Tuen Mun
Ireland	Beaumont Hospital /ID# 157515	Beaumont	Dublin
Ireland	St Vincent's University Hospital /ID# 157512	Elm Park	Dublin
Ireland	University Hospital Galway /ID# 157513	Galway
Israel	Soroka University Medical Center /ID# 157798	Be'er Sheva	HaDarom
Israel	Duplicate_Rambam Medical Center /ID# 171072	Haifa
Israel	The Edith Wolfson Medical Center /ID# 217329	Holon
Israel	Hadassah Medical Center-Hebrew University /ID# 165913	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 163540	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 171073	Jerusalem
Israel	Sheba Medical Center /ID# 157797	Ramat Gan	Tel-Aviv
Israel	Sheba Medical Center /ID# 171074	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 157796	Tel Aviv-Yafo	Tel-Aviv
Italy	A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155635	Bologna
Italy	A.O. Per L'Emergenza Cannizzaro /ID# 161306	Catania
Italy	University of Catanzaro /ID# 212012	Catanzaro	Calabria
Italy	Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 168051	Florence	Toscana
Italy	Ospedale Policlinico San Martino /ID# 162430	Genova
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155633	Milan
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155631	Milano
Italy	Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212019	Modena	Emilia-Romagna
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161305	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155637	Palermo
Italy	Duplicate_Fondazione IRCCS Policlinico San Matteo /ID# 212029	Pavia
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 155636	Rome	Lazio
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166911	Rome	Lazio
Italy	Fondazione PTV Policlinico Tor Vergata /ID# 158021	Rome	Roma
Italy	Policlinico Universitario Campus Bio-Medico /ID# 162429	Rome	Lazio
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155632	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 155634	Rozzano	Milano
Italy	Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162427	Torrette	Ancona
Japan	Tokatsu Tsujinaka Hospital /ID# 163362	Abiko-shi	Chiba
Japan	Tokyo Medical And Dental University, Medical Hospital /ID# 160157	Bunkyo-ku	Tokyo
Japan	Chiba University Hospital /ID# 217532	Chiba-shi	Chiba
Japan	Fukuoka University Hospital /ID# 217792	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 163578	Fukuyama-shi	Hiroshima
Japan	Duplicate_Tokai University Hachioji Hospital /ID# 160160	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 205689	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Mito Medical Center /ID# 160154	Higashi Ibaraki-gun	Ibaraki
Japan	Hiroshima University Hospital /ID# 160139	Hiroshima-shi	Hiroshima
Japan	Gokeikai Ofuna Chuo Hospital /ID# 171070	Kamakura-shi	Kanagawa
Japan	Kanazawa University Hospital /ID# 201766	Kanazawa-shi	Ishikawa
Japan	The Jikei University Kashiwa Hospital /ID# 200007	Kashiwa-shi	Chiba
Japan	Tsujinaka Hospital Kashiwanoha /ID# 213847	Kashiwa-shi	Chiba
Japan	Saitama Medical Center /ID# 160155	Kawagoe-shi	Saitama
Japan	Yamanashi Prefectural Central Hospital /ID# 160156	Kofu-shi	Yamanashi
Japan	Kurume University Hospital /ID# 160138	Kurume-shi	Fukuoka
Japan	Asahikawa Medical University Hospital /ID# 162844	Midorigaokahiga-shi	Hokkaido
Japan	Duplicate_Kitasato University Kitasato Institute Hospital /ID# 160144	Minato-ku	Tokyo
Japan	The Jikei University Hospital /ID# 163190	Minato-ku	Tokyo
Japan	Kyorin University Hospital /ID# 160149	Mitaka-shi	Tokyo
Japan	Aichi Medical University Hospital /ID# 160159	Nagakute-shi	Aichi
Japan	Nagoya City University Hospital /ID# 160162	Nagoya shi	Aichi
Japan	Daido Clinic /ID# 211477	Nagoya-shi	Aichi
Japan	Nagoya University Hospital /ID# 160150	Nagoyashi	Aichi
Japan	Hyogo College of Medicine College Hospital /Id# 160164	Nishinomiya-shi	Hyogo
Japan	Nishinomiya Munic Central Hospital /ID# 210104	Nishinomiya-shi	Hyogo
Japan	Osaka City University Hospital /ID# 160146	Osaka-shi	Osaka
Japan	Shiga University of Medical Science Hospital /ID# 164022	Otsu-shi	Shiga
Japan	Kitasato University Hospital /ID# 171071	Sagamihara-shi	Kanagawa
Japan	Tokitokai Tokito clinic /ID# 160145	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 160161	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160158	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 163028	Sapporo-shi	Hokkaido
Japan	Sapporo Tokushukai Hospital /ID# 213493	Sapporo-shi	Hokkaido
Japan	Duplicate_Tohoku Rosai Hospital /ID# 163189	Sendai-shi	Miyagi
Japan	Tohoku University Hospital /ID# 162843	Sendai-shi	Miyagi
Japan	Tokyo Women's Medical University Hospital /ID# 205973	Shinjuku-ku	Tokyo
Japan	NHO Shizuoka Medical Center /ID# 163029	Sunto-gun	Shizuoka
Japan	Fujita Health University Hospital /ID# 163214	Toyoake-shi	Aichi
Japan	Mie University Hospital /ID# 203639	Tsu-shi	Mie
Japan	Wakayama Medical University Hospital /ID# 200183	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital /ID# 200154	Yamagata-shi	Yamagata
Japan	Yokkaichi Hazu Medical Center /ID# 163741	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 163906	Yokohama shi	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital /ID# 204126	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 158675	Busan
Korea, Republic of	Pusan National University Hospital /ID# 158677	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 158680	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213552	Daejeon
Korea, Republic of	Hanyang University Guri Hospital /ID# 158673	Guri	Gyeonggido
Korea, Republic of	Duplicate_CHA bundang medical center CHA University /ID# 158672	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 158678	Seoul
Korea, Republic of	Kangbuk Samsung Hospital /ID# 158676	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 158674	Seoul
Korea, Republic of	Severance Hospital /ID# 158671	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 158681	Suwon	Gyeonggido
Latvia	Digestive Disease Center Gastro /ID# 163105	Riga
Latvia	Pauls Stradins Clinical University Hospital /ID# 159614	Riga
Latvia	Riga East Clinical University Hospital /ID# 159613	Riga
Lithuania	Duplicate_Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 162582	Kaunas
Lithuania	Duplicate_Vilnius University Hospital /ID# 162507	Vilnius
Malaysia	Queen Elizabeth Hospital /ID# 160654	Division Pantai Barat Utara	Sabah
Malaysia	Universiti Sains Malaysia /ID# 160656	Kelantan
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 163654	Kuala Lumpur	Selangor
Mexico	JM Research SC /ID# 161733	Cuernavaca	Morelos
Mexico	Health Pharma Professional Research S.A de C.V /ID# 161734	Del. Benito Juárez
Mexico	Unidad de Atencion Medica e Investigacion en Salud /ID# 163624	Merida	Yucatan
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 167648	Zapopan	Jalisco
Netherlands	Academisch Medisch Centrum /ID# 157950	Amsterdam
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 163631	Tilburg
New Zealand	Christchurch Hospital /ID# 163074	Christchurch	Canterbury
New Zealand	Dunedin Hospital /ID# 167989	Dunedin	Otago
New Zealand	Wellington Regional Hospital /ID# 167987	Newtown Wellington	Wellington
Norway	Helse More og Romsdal HF, Alesund sjukehus /ID# 212811	Ålesund
Norway	Vestre viken - Baerum Sykehus /ID# 157886	Gjettum
Norway	Sykehuset Levanger Helse NT /ID# 157885	Levanger
Norway	Akershus universitetssykehus /ID# 169378	Nordbyhagen	Akershus
Poland	Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212081	Chojnice	Pomorskie
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212297	Lodz	Lodzkie
Poland	1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209985	Lublin	Lubelskie
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209981	Lublin	Lubelskie
Poland	Wojewodzki Szpital Specjalistyczny /ID# 212402	Olsztyn	Warminsko-mazurskie
Poland	Duplicate_SOLUMED Sp. z o.o., Sp.k. /ID# 160793	Poznan
Poland	Centrum Medyczne Medyk /ID# 212889	Rzeszów	Podkarpackie
Poland	Gastromed /Id# 212099	Torun	Kujawsko-pomorskie
Poland	H-T. Centrum Medyczne - Endoterapia /ID# 212459	Tychy	Slaskie
Poland	Duplicate_Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 205160	Warsaw
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 160797	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 160794	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213579	Warszawa	Mazowieckie
Poland	Planetmed Sp. z o.o. /ID# 202798	Wroclaw	Dolnoslaskie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212602	Wroclaw
Portugal	Hospital Garcia de Orta, EPE /ID# 160747	Almada
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160715	Faro
Portugal	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160739	Guimaraes	Braga
Portugal	Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167749	Lisboa
Portugal	Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160694	Lisboa
Portugal	Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160675	Lisboa
Portugal	Hospital Beatriz Ângelo /ID# 207757	Loures
Portugal	Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167750	Portimão	Faro
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160695	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 160674	Santa Maria Da Feira	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 160697	Viseu
Romania	Tvm Med Serv Srl /Id# 166294	Cluj
Romania	Institutul Clinic Fundeni /ID# 163046	Sector 2	Bucuresti
Romania	Institutul Clinic Fundeni /ID# 163264	Sector 2	Bucuresti
Romania	Cabinet Particular Policlinic Algomed /ID# 163047	Timi?oara
Romania	Duplicate_Centrul Medical Tuculanu SRL /ID# 166295	Timisoara
Russian Federation	Alliance Biomedical Ural Group /ID# 156950	Izhevsk	Udmurtskaya Respublika
Russian Federation	Kuzbass Regional Clinical Hospital /ID# 161310	Kemerovo	Kemerovskaya Oblast
Russian Federation	State Scientific Ctr Coloproct /ID# 204809	Moscow
Russian Federation	Novosibirski Gastrocenter /ID# 217554	Novosibirsk
Russian Federation	Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207440	Perm	Permskiy Kray
Russian Federation	Duplicate_St. Petersburg State Pediatric Medical University /ID# 211977	Saint Petersburg	Sankt-Peterburg
Russian Federation	City Clinical Hospital No. 31 /ID# 208866	St. Petersburg
Russian Federation	Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 156949	Stavropol	Stavropol Skiy Kray
Russian Federation	Tver Regional Clinical Hospital /ID# 205925	Tver	Tverskaya Oblast
Russian Federation	Regional Clinical Hospital #1 /ID# 163453	Tyumen	Tyumenskaya Oblast
Russian Federation	Duplicate_Ulyanovsk State clinical hospi /ID# 156946	Ulyanovsk
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 156976	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 156978	Belgrade	Beograd
Serbia	Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212797	Belgrade
Serbia	Military Medical Academy /ID# 156979	Belgrade	Beograd
Serbia	University Children's Hospital 'Tirsova' /ID# 211481	Belgrade
Serbia	University Clinical Center Serbia /ID# 156973	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 156975	Kragujevac	Sumadijski Okrug
Serbia	General Hospital Leskovac /ID# 209574	Leskovac
Serbia	Clinical Center Vojvodina /ID# 156972	Novi Sad	Vojvodina
Singapore	KL Ling Gastroenterology and Liver Clinic /ID# 205737	Singapore
Singapore	National University Hospital /ID# 160658	Singapore
Singapore	Singapore General Hospital /ID# 160657	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156465	Banska Bystrica
Slovakia	Univerzitna nemocnica Martin /ID# 163200	Martin
Slovakia	KM Management, spol. s.r.o. /ID# 206763	Nitra
Slovakia	GASTRO I., s.r.o. /ID# 156466	Presov
South Africa	Kingsbury Hospital /ID# 163116	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 163115	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 158117	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 163864	Johannesburg	Gauteng
South Africa	Wits Clinical Research Site /ID# 158115	Johannesburg	Gauteng
Spain	Hospital Clinic de Barcelona /ID# 157526	Barcelona
Spain	Hospital Universitario Basurto /ID# 205189	Bilbao	Vizcaya
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157527	Ferrol	A Coruna
Spain	Hospital General Universitario Gregorio Maranon /ID# 161435	Madrid
Spain	Hospital Universitario La Paz /ID# 159228	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157575	Majadahonda	Madrid
Spain	Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159230	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Salamanca /ID# 157532	Salamanca
Spain	Hospital Universitario Virgen Macarena /ID# 160819	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 157530	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 212523	Zaragoza
Spain	Hospital Universitario Miguel Servet /ID# 157531	Zaragoza
Sweden	Sahlgrenska University Hospital /ID# 157879	Gothenburg	Vastra Gotalands Lan
Sweden	Skane University hospital /ID# 211235	Malmo	Skane Lan
Sweden	Duplicate_SU Molndal. /ID# 157880	Molndal
Sweden	Duplicate_Karolinska Univ Sjukhuset /ID# 209966	Solna
Sweden	Danderyd Hospital /ID# 202136	Stockholm	Stockholms Lan
Sweden	Duplicate_GHP Stockholm Gastro Center /ID# 210479	Stockholm	Stockholms Lan
Sweden	Ersta diakoni /ID# 157878	Stockholm	Stockholms Lan
Switzerland	Duplicate_Universitaetsspital Basel /ID# 164555	Basel
Switzerland	Inselspital, Universitätsspital Bern /ID# 163531	Bern
Switzerland	Universitätsspital Zürich /ID# 163532	Zürich	Zuerich
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 162521	????
Ukraine	Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165649	Kharkiv
Ukraine	Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212050	Kherson
Ukraine	Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165651	Kyiv
Ukraine	International Institute of Clinical Research LLC /ID# 211997	Kyiv
Ukraine	Kyiv Railway Clinical Hosp No.2 /ID# 217330	Kyiv
Ukraine	Medical Center of LLC Medbud-Clinic /ID# 216929	Kyiv
Ukraine	Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206788	Lutsk
Ukraine	Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165650	Lviv
Ukraine	Duplicate_Transcarpathian Regional Clin. /ID# 168419	Uzhhorod
Ukraine	MNPE Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrohov /ID# 216265	Vinnytsia
Ukraine	Scientific Research Institute of Invalid Rehabilitation /ID# 211516	Vinnytsia	Vinnytska Oblast
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 158031	Cambridge
United Kingdom	Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207937	Chertsey	Surrey
United Kingdom	NHS Lothian /ID# 207447	Edinburgh
United Kingdom	Royal Devon and Exeter NHS Trust Hospital /ID# 157517	Exeter	Devon
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust /ID# 209569	Huddersfield
United Kingdom	Hull University Teaching Hospitals NHS Trust /ID# 158757	Hull
United Kingdom	Leeds Teaching Hospitals NHS Trust /ID# 157523	Leeds
United Kingdom	Barts Health NHS Trust /ID# 163710	London	London, City Of
United Kingdom	Duplicate_King's College Hospital NHS Foundation Trusts /ID# 158756	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust /ID# 157519	London	London, City Of
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163709	Newcastle Upon Tyne
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 158033	Oxford
United Kingdom	Duplicate_Northern Care Alliance NHS Group /ID# 207764	Salford
United States	University of Michigan Health Systems /ID# 157144	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 159410	Arlington	Texas
United States	Gastroenterology Associates LLC - Jefferson Hwy /ID# 161956	Baton Rouge	Louisiana
United States	Inquest Clinical Research /ID# 165695	Baytown	Texas
United States	Washington Gastroenterology Associates /ID# 162120	Bellevue	Washington
United States	HP Clinical Research /ID# 162998	Bountiful	Utah
United States	Seffner Premier Health Care, PA /ID# 162265	Brandon	Florida
United States	NY Scientific /ID# 158418	Brooklyn	New York
United States	Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 212036	Burnt Hills	New York
United States	Texas Digestive Disease Consultants /ID# 209596	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209785	Cedar Park	Texas
United States	Univ NC Chapel Hill /ID# 154840	Chapel Hill	North Carolina
United States	Medical University of South Carolina /ID# 212579	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 158481	Charlotte	North Carolina
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154839	Chevy Chase	Maryland
United States	Northwestern University Division of GI/Hepatology /ID# 158283	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 157141	Chicago	Illinois
United States	Tri-State Endoscopy /ID# 154933	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc /ID# 204859	Clearwater	Florida
United States	Clinical Research of West Florida, Inc /ID# 207450	Clearwater	Florida
United States	South Lake Pain Institute, Inc /ID# 162825	Clermont	Florida
United States	Cleveland Clinic Main Campus /ID# 208171	Cleveland	Ohio
United States	Peak Gastroenterology Associates, PC /ID# 165834	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 165004	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 167901	Columbus	Ohio
United States	The Ohio State University /ID# 164709	Columbus	Ohio
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 201848	Dallas	Texas
United States	Western Connecticut Medical Group /ID# 165849	Danbury	Connecticut
United States	Hometown Urgent Care and Resea /ID# 170453	Dayton	Ohio
United States	Universal Axon Clinical Research /ID# 165432	Doral	Florida
United States	NorthShore University HealthSystem /ID# 158287	Evanston	Illinois
United States	Plains Clinical Research Center, LLC /ID# 169715	Fargo	North Dakota
United States	Intercity Advanced Gastroentertology Center /ID# 213399	Fresh Meadows	New York
United States	DHAT Research Institute /ID# 158217	Garland	Texas
United States	Gastro One /ID# 154742	Germantown	Tennessee
United States	Duplicate_Long Island Clinical Research /ID# 154836	Great Neck	New York
United States	Gastroenterology Associates, P.A. of Greenville /ID# 154911	Greenville	South Carolina
United States	PennState Milton S.Hershey Med /ID# 154883	Hershey	Pennsylvania
United States	Clinical Trials America /ID# 158484	Hickory	North Carolina
United States	Houma Digestive Health Special /ID# 158286	Houma	Louisiana
United States	Baylor College of Medicine - Baylor Medical Center /ID# 158212	Houston	Texas
United States	Centex Studies, Inc. - Houston /ID# 200720	Houston	Texas
United States	CliniCore International, LLC /ID# 158209	Houston	Texas
United States	Precision Research Institute, LLC /ID# 200503	Houston	Texas
United States	Vilo Research Group Inc /ID# 206130	Houston	Texas
United States	Newport Huntington Medica /ID# 213033	Huntington Beach	California
United States	Nature Coast Clinical Research - Inverness /ID# 159414	Inverness	Florida
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 162388	Jackson	Mississippi
United States	East Tennessee Research Institute /ID# 168737	Johnson City	Tennessee
United States	Vidant Multispecialty Clinic - Kinston /ID# 161111	Kinston	North Carolina
United States	SIH Research Mumtaz, Inc /ID# 163082	Kissimmee	Florida
United States	Las Vegas Medical Research /ID# 160172	Las Vegas	Nevada
United States	Revival Research Institute, Inc /ID# 210984	Las Vegas	Nevada
United States	University of Kentucky Chandler Medical Center /ID# 157137	Lexington	Kentucky
United States	Alliance Medical Research /ID# 163840	Lighthouse Point	Florida
United States	Atria Clinical Research /ID# 164740	Little Rock	Arkansas
United States	Rocky Mountain Pediatric Gastroenterology /ID# 207169	Lone Tree	Colorado
United States	United Medical Doctors /ID# 207040	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162656	Los Angeles	California
United States	TLC Clinical Research Inc /ID# 212503	Los Angeles	California
United States	University of Louisville /ID# 210521	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 154857	Macon	Georgia
United States	Cfagi Llc /Id# 201571	Maitland	Florida
United States	Duplicate_Clinical Neuroscience Solutions /ID# 164181	Memphis	Tennessee
United States	Great Lakes Medical Research, LLC /ID# 201732	Mentor	Ohio
United States	Coral Research Clinic /ID# 158549	Miami	Florida
United States	ITB Research /ID# 161334	Miami	Florida
United States	South Florida Research Ph I-IV, Inc. /ID# 161836	Miami	Florida
United States	Vista Health Research, LLC /ID# 212664	Miami	Florida
United States	WVU Medicine /ID# 167940	Morgantown	West Virginia
United States	United Medical Doctors - Murrieta /ID# 158424	Murrieta	California
United States	Gastroenterology Group Naples /ID# 165206	Naples	Florida
United States	Vanderbilt University Medical Center /ID# 157138	Nashville	Tennessee
United States	Digestive Disease Care /ID# 209619	New Hyde Park	New York
United States	North Shore University Hospital /ID# 168736	New Hyde Park	New York
United States	Delricht Research /ID# 206542	New Orleans	Louisiana
United States	Nola Research Works, LLC /ID# 161330	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 161959	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 161911	New York	New York
United States	Lenox Hill Hospital /ID# 168465	New York	New York
United States	NYU Langone Medical Center /ID# 160171	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 171118	North Massapequa	New York
United States	Southwest Gastroenterology /ID# 165002	Oak Lawn	Illinois
United States	Advanced Research Institute /ID# 154914	Ogden	Utah
United States	Digestive Disease Specialists /ID# 170774	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 211938	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center /ID# 210057	Omaha	Nebraska
United States	Endoscopic Research, Inc. /ID# 205901	Orlando	Florida
United States	Omega Research Maitland, LLC /ID# 171081	Orlando	Florida
United States	IMIC Inc. Medical Research /ID# 154943	Palmetto Bay	Florida
United States	Phoenix VA Health Care System /ID# 162267	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh of UPMC /ID# 210920	Pittsburgh	Pennsylvania
United States	Northwest Gastroenterology Clinic /ID# 158288	Portland	Oregon
United States	Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154880	Raleigh	North Carolina
United States	Rapid City Medical Center - GI Research /ID# 163841	Rapid City	South Dakota
United States	McGuire DV AMC /ID# 159990	Richmond	Virginia
United States	Southern CA Research Ctr., Inc /ID# 167875	Riverside	California
United States	Mayo Clinic - Rochester /ID# 163085	Rochester	Minnesota
United States	St. Louis University /ID# 161902	Saint Louis	Missouri
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 161336	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 168770	San Antonio	Texas
United States	University of California, San Francisco /ID# 157143	San Francisco	California
United States	HonorHealth Research Institute - Shea /ID# 161783	Scottsdale	Arizona
United States	Virginia Mason - Seattle Orthapedics /ID# 155545	Seattle	Washington
United States	Louisana Research Center, LLC /ID# 162236	Shreveport	Louisiana
United States	Clinical Research Trials of Florida, Inc. /ID# 201014	Tampa	Florida
United States	Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211883	Tempe	Arizona
United States	Cotton-O'Neil Clinical Res Ctr /ID# 154738	Topeka	Kansas
United States	Center for Digestive Health /ID# 154690	Troy	Michigan
United States	University of Arizona /ID# 158469	Tucson	Arizona
United States	Adult Gastroenterology Associates - Gen 1 Research /ID# 206125	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 166796	Tyler	Texas
United States	Gastro Health & Nutrition - Victoria /ID# 164296	Victoria	Texas
United States	Cedars-Sinai Medical Center-West Hollywood /ID# 163842	West Hollywood	California
United States	Velocity Clinical Research - Salt Lake City /ID# 161781	West Jordan	Utah
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161328	Wyoming	Michigan
United States	Digestive Disease Associates, LTD /ID# 208847	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Hong Kong,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  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	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.	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	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

External Links

•   Related info