Crohn's Disease Clinical Trials

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A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

Status: Recruiting
Location: See all (153) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy

• Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450

• Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:

‣ a minimum score of 1 for the component of size of ulcers AND

⁃ a minimum score of 1 for the component of ulcerated surface

• In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study

• Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

Locations
United States
Alabama
Digestive Health Specialists of the Southeast
RECRUITING
Dothan
East View Medical Research
RECRUITING
Mobile
California
Clinnova Research
RECRUITING
Anaheim
Gastro Care Institute
RECRUITING
Lancaster
United Gastroenterologists
RECRUITING
Los Alamitos
GastroIntestinal Bioscience
RECRUITING
Los Angeles
TLC Clinical Research Inc
RECRUITING
Los Angeles
Hoag Memorial Hospital
SUSPENDED
Newport Beach
Medical Associates Research Group, Inc.
RECRUITING
San Diego
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Connecticut
Medical Research Center of Connecticut
RECRUITING
Hamden
Florida
Green Leaf Clinical Trials
RECRUITING
Jacksonville
Biodax Medical Research Trials
RECRUITING
Miami
Sanchez Clinical Research, Inc
RECRUITING
Miami
GI Pros Research
RECRUITING
Naples
GCP Clinical Research
RECRUITING
Tampa
Georgia
Atlanta Gastroenterology Associates
SUSPENDED
Atlanta
Morehouse School of Medicine
RECRUITING
Atlanta
Gastroenterology Associates of Central GA
RECRUITING
Macon
Illinois
Comprehensive Gastrointestinal Health Libertyville
SUSPENDED
Northbrook
Kansas
Cotton-O'Neil Clinical Research Center
RECRUITING
Topeka
Louisiana
Gastroenterology Clinic of Acadiana
RECRUITING
Lafayette
Massachusetts
Lucida Clinical Trials
RECRUITING
New Bedford
Maryland
Woodholme Gastroenterology Associates
RECRUITING
Glen Burnie
Michigan
Michigan Center of Medical Research
RECRUITING
Farmington Hills
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Charlotte Gastroenterology and Hepatology, PLLC
RECRUITING
Charlotte
New York
Westchester Putnam Gastroenterology
RECRUITING
Carmel
New York Gastroenterology Associates
RECRUITING
New York
Ohio
Great Lakes Gastroenterology Research, LLC
RECRUITING
Mentor
Oklahoma
Digestive Disease Specialists Inc
RECRUITING
Oklahoma City
Pennsylvania
Frontier Clinical Research
RECRUITING
Uniontown
South Carolina
Palmetto Primary and Specialty Care Physicians, Charleston
RECRUITING
Summerville
Texas
DFW Clinical Trials
RECRUITING
Carrollton
UT Southwestern
SUSPENDED
Dallas
Lubbock Gastroenterology
RECRUITING
Lubbock
Gastroenterology Research of America, LLC
RECRUITING
San Antonio
Southern Star Research Institute, LLC
RECRUITING
San Antonio
The University of Texas Health Science Center at Tyler
RECRUITING
Tyler
Other Locations
Austria
LKH-Univ. Klinikum Graz
RECRUITING
Graz
Medizinische Universitatsklinik Innsbruck
RECRUITING
Innsbruck
Kepler Universitatsklinikum GmbH
RECRUITING
Linz
LKH - Universitätsklinikum der PMU Salzburg
RECRUITING
Salzburg
Krankenhaus der Barmherzigen Brüder
RECRUITING
Vienna
Klinikum Wels Grieskirchen
RECRUITING
Wels
Universitatsklinikum Wiener Neustadt
RECRUITING
Wiener Neustadt
Belgium
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
ULB Erasme Ziekenhuis
RECRUITING
Brussels
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Ghent University Hospital
RECRUITING
Ghent
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
CHU de Liege
RECRUITING
Liège
Algemeen Ziekenhuis Delta
RECRUITING
Roeselare
Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
RECRUITING
Edmonton
Charlton Digestive Disease Centre
RECRUITING
Hamilton
London Digestive Disease Institute
RECRUITING
London
Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Clinique IMD
RECRUITING
Montreal
Taunton Surgical Centre
RECRUITING
Oshawa
Toronto Immune and Digestive Health Institute Inc
RECRUITING
Toronto
GIRI Gastrointestinal Research Institute
RECRUITING
Vancouver
China
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
Chongqing General Hospital
RECRUITING
Chongqing
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Sixth Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
Zhongda Hospital Southeast University
RECRUITING
Nanjing
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Denmark
Aarhus University Hospital
RECRUITING
Aarhus C
Sydvestjysk Sygehus
RECRUITING
Esbjerg
NAU New Aalborg University Hospital
RECRUITING
Gistrup
Herlev Hospital
RECRUITING
Herlev
Nordsjaellands Hospital, Hillerod
RECRUITING
Hilleroed
Hvidovre Hospital
RECRUITING
Hvidovre
Bispebjerg Hospital
RECRUITING
København Nv
Odense UH og Svendberg sygehus
RECRUITING
Odense C
France
CHU Amiens Picardie
RECRUITING
Amiens
Clermont Ferrand University Hospital
RECRUITING
Clermont-ferrand
Institut Prive MICI Clinique des Cedres
RECRUITING
Échirolles
Aphm - Hopital Nord
RECRUITING
Marseille
CHU Nantes - Hotel Dieu
RECRUITING
Nantes
Clinique Ambroise Pare
RECRUITING
Neuilly-sur-seine
CHU Nimes
RECRUITING
Nîmes
APHP - Hopital Bichat - Claude Bernard
RECRUITING
Paris
Aphp Hopital Saint Antoine
RECRUITING
Paris
Hospices Civils de Lyon CHU Lyon Sud
RECRUITING
Pierre-bénite
CHU de Reims
RECRUITING
Reims
Centre Hospitalier Universitaire de Nancy - Hôpital Central
RECRUITING
Vandœuvre-lès-nancy
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
RECRUITING
Berlin
GASTRO-Studien
RECRUITING
Berlin
Universitatsklinikum Erlangen
RECRUITING
Erlangen
Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich
RECRUITING
Grevenbroich
Universitatsklinikum Jena
RECRUITING
Jena
Universitatsklinikum Schleswig Holstein Kiel
RECRUITING
Kiel
St. Marien und St. Annastiftskrankenhaus
RECRUITING
Ludwigshafen Am Rhein
Universitaetsklinikum Mannheim
RECRUITING
Mannheim
Klinikum rechts der Isar der TU Munchen
RECRUITING
München
Hungary
Endomedix
RECRUITING
Budapest
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Budapest
Pannónia Magánorvosi Centrum Kft
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Semmelweis Egyetem 1
RECRUITING
Budapest
Semmelweis Egyetem 2
RECRUITING
Budapest
Clinexpert Gyongyos Kft
RECRUITING
Gyöngyös
Szegedi Tudomanyegyetem
RECRUITING
Szeged
Italy
A O U Sant Orsola Malpighi
RECRUITING
Bologna
Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
RECRUITING
Bolzano
Azienda Ospedaliero Universitaria San Martino
RECRUITING
Genova
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Ospedale Mauriziano Torino
RECRUITING
Torino
Netherlands
Maastricht UMC
RECRUITING
Maastricht
Radboud Umcn
RECRUITING
Nijmegen
St. Elisabeth Ziekenhuis
RECRUITING
Tilburg
Poland
Centrum Medyczne Medis ManerMed Sp Z O O
RECRUITING
Bydgoszcz
Centrum Medyczne Plejady
RECRUITING
Krakow
Centrum Medyczne Promed
RECRUITING
Krakow
Centrum Medyczne 'Medyk' Sp. z o.o. K.
RECRUITING
Rzeszów
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
RECRUITING
Torun
Medical Network Sp z o o
RECRUITING
Warsaw
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
RECRUITING
Warsaw
Slovakia
FNsP F. D. Roosevelta Banska Bystrica
RECRUITING
Banská Bystrica
Cliniq s.r.o.
RECRUITING
Bratislava
ENDOMED s.r.o
RECRUITING
Košice
Fakultna nemocnica s poliklinikou Nove Zamky
RECRUITING
Nové Zámky
GASTRO I. s.r.o.
RECRUITING
Prešov
Gastro LM s.r.o.
RECRUITING
Prešov
Vseobecna nemocnica Rimavska Sobota
RECRUITING
Rimavská Sobota
Spain
Hosp. Gral. Univ. Dr. Balmis
RECRUITING
Alicante
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Hosp. Arquitecto Marcide
RECRUITING
Ferrol
Hosp. de Cabuenes
RECRUITING
Gijón
Hosp. Univ. Dr. Josep Trueta
RECRUITING
Girona
Hosp. Univ. de Torrejon
RECRUITING
Madrid
Hosp. de Navarra
RECRUITING
Navarra
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Hosp. Virgen Macarena
RECRUITING
Seville
Sweden
Linkoping University Hospital
RECRUITING
Linköping
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
RECRUITING
Mölndal
Ersta sjukhus
RECRUITING
Stockholm
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Sodersjukhuset
RECRUITING
Stockholm
Akademiska Sjukhuset
RECRUITING
Uppsala
United Kingdom
Barts Health NHS Trust
RECRUITING
Greater London
London North West University Healthcare NHS Trust
RECRUITING
Greater London
West Middlesex University Hospital
RECRUITING
Iselworth
Chelsea And Westminster Hospital
RECRUITING
London
Imperial College London
RECRUITING
London
Royal Free Hospital
RECRUITING
London
University College London Hospitals Nhs Foundation Trust
RECRUITING
London
Norfolk and Norwich University Hospital
RECRUITING
Norwich
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2026-04-21
Estimated Completion Date: 2030-12-11
Participants
Target number of participants: 530
Treatments
Experimental: Guselkumab
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
Experimental: Risankizumab
Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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