Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

Crohn's Disease (CD) Clinical Trial

— SEQUENCE  

Official title:

A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04524611
• Other study ID #: M20-259
• Secondary ID: 2020-002674-26
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 30, 2020
• Est. completion date: February 11, 2028

Study information

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

Clinical Trial Summary

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 527
• Est. completion date: February 11, 2028
• Est. primary completion date: February 11, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of Crohn's disease (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 Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
• Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.

Exclusion Criteria:

• Current diagnosis of ulcerative colitis or indeterminate colitis.
• Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
• Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
• Currently know complications of CD (strictures, short bowel, etc).

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease (CD)

Intervention

Drug:
• Risankizumab
Intravenous (IV) Infusion
• Risankizumab
Subcutaneous (SC) Injection
• Ustekinumab
Intravenous (IV) infusion
• Ustekinumab
Subcutaneous (SC) injection

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires /ID# 224550	Ciudad Autonoma Buenos Aires	Ciudad Autonoma De Buenos Aires
Argentina	Cemic /Id# 223670	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	CINME Centro de Investigaciones Metabolicas /ID# 223447	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Gedyt /ID# 224698	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 223432	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Privado Univesitario /ID# 223433	Cordoba
Argentina	Sanatorio 9 de Julio /ID# 226086	San Miguel de Tucuman	Tucuman
Australia	Monash Medical Centre /ID# 224599	Clayton	Victoria
Australia	Lyell McEwin Hospital /ID# 223643	Elizabeth Vale	South Australia
Australia	Mater Misericordiae Limited /ID# 223642	South Brisbane	Queensland
Australia	Griffith University /ID# 223641	Southport	Queensland
Australia	Wollongong Hospital /ID# 224688	Wollongong	New South Wales
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440	Linz	Oberoesterreich
Austria	Universitaetsklinikum St. Poelten /ID# 223437	Sankt Poelten	Niederoesterreich
Austria	Medizinische Universitaet Wien /ID# 223438	Vienna	Wien
Belgium	Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 223902	Brussels	Bruxelles-Capitale
Belgium	AZ Maria Middelares /ID# 223908	Gent
Belgium	UZ Gent /ID# 223899	Gent	Oost-Vlaanderen
Belgium	CHU UCL Namur - site Godinne /ID# 223905	Godinne	Namur
Belgium	Universitair Ziekenhuis Leuven /ID# 223901	Leuven	Vlaams-Brabant
Belgium	CHU de Liege /ID# 223904	Liege
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 223898	Liege
Belgium	ZNA - Jan Palfijn /ID# 223907	Merksem
Belgium	AZ-Delta /ID# 223896	Roeselare	West-Vlaanderen
Belgium	Vitaz /Id# 224511	Sint-Niklaas
Belgium	UCL Saint-Luc /ID# 223900	Woluwe-Saint-Lambert	Bruxelles-Capitale
Brazil	Upeclin Fmb - Unesp /Id# 223234	Botucatu	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 223233	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 223231	Santo André	Sao Paulo
Brazil	Kaiser Clinica e Hospital Dia /ID# 223232	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Kaspela EOOD /ID# 223415	Plovdiv
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757	Sofia
Bulgaria	Second MHAT Sofia /ID# 223425	Sofia
Bulgaria	UMHAT Tsaritsa Joanna - ISUL /ID# 223822	Sofia
Canada	University of Calgary /ID# 223750	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 223755	Edmonton	Alberta
Canada	Covenant Health /ID# 223753	Edmonton	Alberta
Canada	CISSS de la Monteregie /ID# 224399	Greenfield Park	Quebec
Canada	QEII - Health Sciences Centre /ID# 223748	Halifax	Nova Scotia
Canada	CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744	Levis	Quebec
Canada	London Health Sciences Center- University Hospital /ID# 223741	London	Ontario
Canada	Montreal General Hospital- McGill University Health Center /ID# 223743	Montreal
Canada	Fraser Clinical Trials Inc /ID# 223742	New Westminster	British Columbia
Canada	Scott Shulman Medicine Professional Corporation /ID# 223754	North Bay	Ontario
Canada	CHUS - Hopital Fleurimont /ID# 224819	Sherbrooke	Quebec
Canada	Axler, Toronto, ON. Canada /ID# 223740	Toronto	Ontario
Canada	Mount Sinai Hospital /ID# 223752	Toronto	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 223747	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 223668	Concepción
Chile	Sociedad de Servicios Medicos Walsen Galmez /ID# 224032	Santiago	Region Metropolitana Santiago
Chile	Hospital Las Higueras /ID# 223669	Talcahuano
China	Peking University Third Hospital /ID# 224479	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University /ID# 224684	Changsha
China	The Third Xiangya Hospital of Central South University /ID# 224754	Changsha	Hunan
China	Changzhou No.2 People's Hospital /ID# 238965	Changzhou	Jiangsu
China	West China Hospital, Sichuan University /ID# 224786	Chengdu	Sichuan
China	Chongqing General Hospital /ID# 232305	Chongqing	Chongqing
China	The Sixth Affiliated Hosp Sun /ID# 224416	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University /ID# 224524	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University school of Medicine /ID# 224662	Hangzhou	Zhejiang
China	Anhui Provincial Hospital /ID# 224832	Hefei	Anhui
China	The First Affiliated Hospital of Nanchang University /ID# 224507	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital /ID# 224746	Nanjing	Jiangsu
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 224478	Shenyang
China	Renmin Hospital of Wuhan University /ID# 224525	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of HUST /ID# 224428	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545	Wuhan	Hubei
China	Wuxi People's Hospital /ID# 224426	Wuxi	Jiangsu
China	Zhongshan Hospital Xiamen University /ID# 224663	Xiamen	Fujian
China	The Second Affiliated Hospital of Zhengzhou University /ID# 224528	Zhengzhou	Henan
Czechia	Nemocnice Ceske Budejovice a.s. /ID# 224219	Ceske Budejovice
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 223277	Hradec Kralove
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 223256	Pardubice
Czechia	Axon Clinical, s.r.o. /ID# 223260	Praha
Czechia	ISCARE a.s. /ID# 223279	Praha
Czechia	Nemocnice Horovice - NH Hospital a.s /ID# 223276	Praha
France	CHU Clermont-Ferrand /ID# 224529	Clermont	Auvergne-Rhone-Alpes
France	Hopital Beaujon /ID# 223863	Clichy	Ile-de-France
France	CHU Grenoble - Hopital Michallon /ID# 224091	La Tronche
France	CHRU Lille - Hopital Claude Huriez /ID# 223765	Lille	Hauts-de-France
France	APHM - Hopital Nord /ID# 223869	Marseille	Bouches-du-Rhone
France	CHU Montpellier - Hôpital Saint Eloi /ID# 223860	Montpellier Cedex 5	Herault
France	CHU de Nantes, Hotel Dieu -HME /ID# 241098	Nantes	Pays-de-la-Loire
France	Clinique Jules Verne /ID# 223870	Nantes
France	Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249859	Neuilly Sur Seine	Ile-de-France
France	Chu de Nice-Hopital L'Archet Ii /Id# 223763	Nice	Alpes-Maritimes
France	Polyclinique Grand Sud /ID# 224092	Nimes Cedex
France	CHU Bordeaux - Hopital Haut Leveque /ID# 223764	Pessac	Gironde
France	CHU Reims - Hôpital Robert Debre /ID# 224530	Reims CEDEX	Marne
France	CHU de SAINT ETIENNE - Hopital Nord /ID# 223768	St. Priest En Jarez	Loire
France	Hopital Universitaire Purpan Hopital Rangueil /ID# 224732	Toulouse
France	CHRU Nancy - Hopitaux de Brabois /ID# 223767	Vandoeuvre-les-Nancy	Meurthe-et-Moselle
Germany	Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405	Berlin
Germany	DRK Kliniken Berlin Westend /ID# 223412	Berlin
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411	Berlin
Germany	Praxis Dr. Michael Mross /ID# 229110	Berlin
Germany	Krankenhaus Waldfriede /ID# 223397	Berlin-Zehlendorf
Germany	Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403	Dresden
Germany	Universitaetsklinikum Erlangen /ID# 223404	Erlangen	Bayern
Germany	Agaplesion Markus Krankenhaus /ID# 223673	Frankfurt am Main
Germany	Universitaetsklinikum Frankfurt /ID# 223396	Frankfurt am Main	Hessen
Germany	Universitaetsklinikum Freiburg /ID# 223406	Freiburg	Baden-Wuerttemberg
Germany	Praxiszentrum fuer Gastroenterologie /ID# 223409	Grevenbroich	Nordrhein-Westfalen
Germany	Medizinische Hochschule Hannover /ID# 223402	Hannover
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395	Kiel	Schleswig-Holstein
Germany	EUGASTRO GmbH /ID# 223401	Leipzig
Germany	Klinikum Lueneburg /ID# 223408	Lueneburg
Germany	Otto-von-Guericke-Universitaet /ID# 223413	Magdeburg
Germany	Universitatsklinikum Mannheim /ID# 223410	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 224552	Muenster
Germany	Universitatsklinik Regensburg /ID# 223407	Ratisbon	Bayern
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482	Saarbrücken	Saarland
Germany	Universitaetsklinikum Ulm /ID# 223400	Ulm	Baden-Wuerttemberg
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338	Athens
Greece	General Hospital of Athens Ippokratio /ID# 223344	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 223336	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 223339	Ioannina
Greece	General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340	Pireaus
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 223887	Thessaloniki
Hungary	Clinexpert Kft /ID# 223775	Budapest
Hungary	Semmelweis Egyetem /ID# 223772	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 223773	Debrecen	Hajdu-Bihar
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774	Szeged	Csongrad
Hungary	Clinfan Szolgaltato Kft. /ID# 224751	Szekszard
Israel	Soroka University Medical Center /ID# 223556	Beer Sheva	HaDarom
Israel	The Edith Wolfson Medical Center /ID# 227652	Holon
Israel	Shaare Zedek Medical Center /ID# 223549	Jerusalem
Israel	Rabin Medical Center /ID# 223558	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 223557	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 223551	Tel Aviv-Yafo	Tel-Aviv
Israel	Assaf Harofeh Medical Center /ID# 224686	Zerifin
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330	Bologna
Italy	Azienda Ospedaliera G. Brotzu /ID# 241165	Cagliari
Italy	Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474	Cagliari
Italy	Ospedale Policlinico San Martino /ID# 223329	Genoa	Genova
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324	Milan
Italy	Ospedale San Raffaele IRCCS /ID# 241167	Milan	Milano
Italy	ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322	Milano
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333	Palermo
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 223325	Rome	Lazio
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332	Rome	Roma
Italy	Policlinico Agostino Gemelli /ID# 223323	Rome	Lazio
Korea, Republic of	Dong-A University Hospital /ID# 223455	Busan
Korea, Republic of	The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456	Daejeon
Korea, Republic of	Kangbuk Samsung Hospital /ID# 223452	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 223453	Seoul
Mexico	BRCR Global México /ID# 223970	Guadalajara	Jalisco
Mexico	Medical Care & Research SA de CV /ID# 223974	Mérida	Yucatan
Mexico	Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179	Mexicali	Baja California
Mexico	Centro Medico Zambrano Hellion /ID# 224025	San Pedro Garza Garcia	Nuevo Leon
Mexico	Faicic S de Rl de Cv /Id# 226990	Veracruz
Netherlands	Academisch Medisch Centrum /ID# 223228	Amsterdam
Netherlands	Radboud Universitair Medisch Centrum /ID# 233750	Nijmegen	Gelderland
Netherlands	Elisabeth Tweesteden Ziekenhuis /ID# 223229	Tilburg
Netherlands	Universitair Medisch Centrum Utrecht /ID# 223696	Utrecht
Poland	Malopolskie Centrum Kliniczne /ID# 223708	Krakow	Malopolskie
Poland	Gastromed Sp. z o.o /ID# 223705	Torun	Kujawsko-pomorskie
Poland	NZOZ Vivamed Jadwiga Miecz /ID# 223706	Warszawa	Mazowieckie
Romania	Institutul Clinic Fundeni /ID# 223914	Bucharest	Bucuresti
Romania	Sana Monitoring /Id# 223682	Bucharest
Romania	Spitalul Clinic Colentina /ID# 223680	Bucuresti
Romania	Univ Emergency Hosp Bucharest /ID# 223579	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017	Targu Mures
Romania	Targu Mures Emergency Clinical County Hospital /ID# 223613	Targu Mures
Romania	Cabinet Particular Policlinic Algomed /ID# 223578	Timi?oara
Russian Federation	Immanuel Kant Baltic Federal University /ID# 224224	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222	Moscow
Russian Federation	City Clinical Hospital No. 31 /ID# 224223	St. Petersburg
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302	Banska Bystrica
Slovakia	KM Management, spol. s.r.o. /ID# 223304	Nitra
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580	Nove Zamky
Slovakia	GASTRO I., s.r.o. /ID# 223303	Presov
South Africa	Dr MJ Prins /ID# 224304	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 223805	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 223803	CAPE TOWN Milnerton	Western Cape
South Africa	Lenasia Clinical Trial Centre /ID# 224306	Johannesburg	Gauteng
Spain	Hospital General Universitario de Alicante Doctor Balmis /ID# 223552	Alicante
Spain	Hospital Universitario Germans Trias i Pujol /ID# 223436	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona /ID# 223355	Barcelona
Spain	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356	Ferrol	A Coruna
Spain	Hospital Universitario de Fuenlabrada /ID# 223371	Fuenlabrada	Madrid
Spain	Hospital Universitario de Bellvitge /ID# 225719	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Clinico Universitario San Carlos /ID# 223367	Madrid
Spain	Hospital General Universitario Gregorio Maranon /ID# 223317	Madrid
Spain	Hospital Universitario La Paz /ID# 223318	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 223319	Majadahonda	Madrid
Spain	Hospital Universitario Central de Asturias /ID# 223368	Oviedo	Asturias
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 226554	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen del Rocio /ID# 223476	Sevilla
Spain	Hospital Universitario Virgen Macarena /ID# 223315	Sevilla
Spain	Hospital Clinico Universitario de Valencia /ID# 223321	Valencia
Spain	Hospital Universitario y Politecnico La Fe /ID# 223314	Valencia
Sweden	Falu Lasarett /ID# 227222	Falun
Sweden	Karolinska University Hospital Solna /ID# 223423	Solna	Stockholms Lan
Sweden	Danderyds sjukhus AB /ID# 223363	Stockholm
Sweden	GHP Stockholm Gastro Center /ID# 223420	Stockholm	Stockholms Lan
Switzerland	Universitätsspital Basel /ID# 223711	Basel	Basel-Stadt
Switzerland	Inselspital, Universitätsspital Bern /ID# 223590	Bern
Switzerland	Universitatsspital Zurich /ID# 223712	Zurich	Zuerich
Turkey	Ankara Univ Medical Faculty /ID# 223388	Ankara
Turkey	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387	Istanbul
Turkey	Mersin University Medical /ID# 223385	Mersin
Turkey	Gazi Universitesi Tip Fakultes /ID# 223386	Yenimahalle	Ankara
Ukraine	Kyiv Municipal Clinical Hospital #18 /ID# 223700	Kyiv
Ukraine	Lviv Regional Clinical Hospital /ID# 223661	Lviv
Ukraine	Medical Center of LLC DIASERVIS /ID# 224249	Zaporizhzhia
United Kingdom	Belfast Health and Social Care Trust /ID# 224023	Belfast
United Kingdom	Cambridge University Hospitals NHS Foundation Trust /ID# 223648	Cambridge
United Kingdom	NHS Lothian /ID# 223646	Edinburgh
United Kingdom	Royal Devon and Exeter NHS Foundation Trust /ID# 223644	Exeter
United Kingdom	NHS Greater Glasgow and Clyde /ID# 223653	Glasgow	Scotland
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust /ID# 223654	Huddersfield
United Kingdom	Barts Health NHS Trust /ID# 223651	London	London, City Of
United Kingdom	Guys and St Thomas NHS Foundation Trust /ID# 223647	London	London, City Of
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 223649	London
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655	Newcastle upon Tyne
United Kingdom	Nottingham University Hospitals NHS Trust /ID# 224179	Nottingham	Nottinghamshire
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 223645	Oxford	Oxfordshire
United Kingdom	Northern Care Alliance NHS Group /ID# 223650	Salford
United Kingdom	University Hospital Southampton NHS Foundation Trust /ID# 224351	Southampton	Hampshire
United Kingdom	East and North Hertfordshire NHS Trust /ID# 224607	Stevenage	Hertfordshire
United Kingdom	NHS Forth Valley /ID# 224657	Stirling
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 223656	Tooting
United States	Univ New Mexico /ID# 223515	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597	Ann Arbor	Michigan
United States	Atlanta Gastro Assoc /ID# 223537	Atlanta	Georgia
United States	GI Alliance /ID# 223508	Baton Rouge	Louisiana
United States	Beth Israel Deaconess Medical Center /ID# 228094	Boston	Massachusetts
United States	Massachusetts General Hospital /Id# 224335	Boston	Massachusetts
United States	NY Scientific /ID# 223479	Brooklyn	New York
United States	University of Vermont Medical Center /ID# 224047	Burlington	Vermont
United States	Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048	Burnt Hills	New York
United States	Advanced Gastroenterology, P.C /ID# 224396	Chandler	Arizona
United States	Univ NC Chapel Hill /ID# 224405	Chapel Hill	North Carolina
United States	Medical University of South Carolina /ID# 223485	Charleston	South Carolina
United States	MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499	Chevy Chase	Maryland
United States	The University of Chicago DCAM /ID# 223520	Chicago	Illinois
United States	University of Cincinnati /ID# 224614	Cincinnati	Ohio
United States	Cleveland Clinic Main Campus /ID# 223691	Cleveland	Ohio
United States	Consultants in Gastroenterology - Columbia NE /ID# 224263	Columbia	South Carolina
United States	Gastro Center of Maryland /ID# 223518	Columbia	Maryland
United States	Gastro One /ID# 223539	Cordova	Tennessee
United States	Southern California Res. Ctr. /ID# 223484	Coronado	California
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512	Dallas	Texas
United States	Western Connecticut Medical Group /ID# 223478	Danbury	Connecticut
United States	Omega Research Maitland, LLC /ID# 223463	DeBary	Florida
United States	NorthShore University HealthSystem /ID# 223538	Evanston	Illinois
United States	Plains Clinical Research Center, LLC /ID# 223522	Fargo	North Dakota
United States	AA Medical Research Center - Flint /ID# 224384	Flint	Michigan
United States	Intercity Advanced Gastroentertology Center /ID# 224313	Fresh Meadows	New York
United States	DHAT Research Institute /ID# 223521	Garland	Texas
United States	Gastroenterology Associates, P.A. of Greenville /ID# 223497	Greenville	South Carolina
United States	Medical Research Center of CT /ID# 223540	Hamden	Connecticut
United States	Penn State Milton S. Hershey Medical Center /ID# 224216	Hershey	Pennsylvania
United States	Baylor College of Medicine - Baylor Medical Center /ID# 223488	Houston	Texas
United States	Vilo Research Group Inc /ID# 223513	Houston	Texas
United States	Nature Coast Clinical Research - Inverness /ID# 223600	Inverness	Florida
United States	Hoag Memorial Hosp Presbyterian /ID# 224373	Irvine	California
United States	Las Vegas Medical Research /ID# 223533	Las Vegas	Nevada
United States	United Medical Doctors /ID# 223486	Los Alamitos	California
United States	TLC Clinical Research Inc /ID# 223467	Los Angeles	California
United States	University of Louisville /ID# 223471	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 223525	Macon	Georgia
United States	University of Miami /ID# 223496	Miami	Florida
United States	West Virginia University Hospitals /ID# 223501	Morgantown	West Virginia
United States	Gastroenterology Group Naples /ID# 223516	Naples	Florida
United States	Vanderbilt University Medical Center /ID# 224610	Nashville	Tennessee
United States	Yale Univ Digestive Diseases /ID# 224463	New Haven	Connecticut
United States	North Shore University Hospital /ID# 224356	New Hyde Park	New York
United States	Nola Research Works, LLC /ID# 223489	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 223470	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 224215	New York	New York
United States	Lenox Hill Hospital /ID# 223534	New York	New York
United States	The Mount Sinai Hospital /ID# 223687	New York	New York
United States	Southwest Gastroenterology /ID# 223509	Oak Lawn	Illinois
United States	Digestive Disease Specialists /ID# 223528	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 223566	Oklahoma City	Oklahoma
United States	Endoscopic Research, Inc. /ID# 223505	Orlando	Florida
United States	Hunter Holmes McGuire VA Medical Center /ID# 223586	Richmond	Virginia
United States	Mayo Clinic - Rochester /ID# 223506	Rochester	Minnesota
United States	UC Davis Medical Center /ID# 225700	Sacramento	California
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 223510	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 223598	San Antonio	Texas
United States	University of California, San Francisco /ID# 223621	San Francisco	California
United States	Guthrie Medical Group, PC /ID# 223910	Sayre	Pennsylvania
United States	Harborview Medical Center /ID# 224464	Seattle	Washington
United States	Virginia Mason Medical Center /ID# 224253	Seattle	Washington
United States	Louisiana Research Center, LLC /ID# 223503	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants - Southlake /ID# 224264	Southlake	Texas
United States	DSI Research, LLC /ID# 234116	Springboro	Ohio
United States	University of South Florida /ID# 224733	Tampa	Florida
United States	Tyler Research Institute, LLC /ID# 223469	Tyler	Texas
United States	Wake Forest Baptist Medical Center /ID# 224406	Winston-Salem	North Carolina
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465	Wyoming	Michigan
United States	Digestive Disease Associates, LTD /ID# 223462	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Clinical Remission at Week 24	Clinical remission is defined as Crohn's disease activity index (CDAI)<150.	Week 24
Primary	Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.	Week 48
Primary	Number of Participants Reporting Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.	Up to 220 Weeks
Secondary	Percentage of Participants Achieving Clinical Remission at Week 48	Clinical remission is defined as Crohn's disease activity index (CDAI)<150.	Week 48
Secondary	Percentage of Participants Achieving Endoscopic Response at Week 48	Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (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 48
Secondary	Percentage of Participants Achieving Endoscopic Response at Week 24	Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (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 24
Secondary	Percentage of Participants Achieving Steroid-Free Endoscopic Remission	Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.	Week 48
Secondary	Percentage of Participants Achieving Steroid-Free Clinical Remission	Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.	Week 48

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