A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
CHARGE
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
1 other identifier
interventional
530
17 countries
144
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2026
Longer than P75 for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
March 30, 2026
CompletedStudy Start
First participant enrolled
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 11, 2030
July 31, 2026
July 1, 2026
2.6 years
March 23, 2026
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Deep Remission at Week 52
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (\<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (\>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
At Week 52
Secondary Outcomes (7)
Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52
At Week 52
Number of Participants with Endoscopic Remission at Week 52
At Week 52
Number of Participants with Clinical Remission at Week 52
At Week 52
Number of Participants with Steroid-Free Clinical Remission at Week 52
At Week 52
Number of Participants with Abnormalities in Laboratory Parameters
Up to Week 148
- +2 more secondary outcomes
Study Arms (2)
Guselkumab
EXPERIMENTALParticipants 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.
Risankizumab
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
- Currently has or is suspected to have an abscess
- Has an active fistula during screening or at Week 0 with an anticipated need for surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
- Currently has a malignancy or has a history of malignancy within 5 years before screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (144)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
East View Medical Research
Mobile, Alabama, 36608, United States
Clinnova Research
Anaheim, California, 92805, United States
United Gastroenterologists
Los Alamitos, California, 90720, United States
TLC Clinical Research Inc
Los Angeles, California, 90048, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
Green Leaf Clinical Trials
Jacksonville, Florida, 32258, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157-6575, United States
Biodax Medical Research Trials
Miami, Florida, 33186, United States
GI Pros Research
Naples, Florida, 34102, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Gastroenterology Associates of Central GA
Macon, Georgia, 31201, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, 70503, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334, United States
Westchester Putnam Gastroenterology
Carmel, New York, 10512, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73114, United States
Frontier Clinical Research
Uniontown, Pennsylvania, 15401, United States
Palmetto Primary and Specialty Care Physicians, Charleston
Summerville, South Carolina, 29486, United States
DFW Clinical Trials
Carrollton, Texas, 75010, United States
Lubbock Gastroenterology
Lubbock, Texas, 79424, United States
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
LKH-Univ. Klinikum Graz
Graz, 8036, Austria
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, 1020, Austria
Klinikum Wels Grieskirchen
Wels, 4600, Austria
Universitatsklinikum Wiener Neustadt
Wiener Neustadt, 2700, Austria
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
CHU de Liege
Liège, 4000, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Charlton Digestive Disease Centre
Hamilton, Ontario, L8N1Y2, Canada
London Digestive Disease Institute
London, Ontario, N6K 1M6, Canada
Taunton Surgical Centre
Oshawa, Ontario, L1J 0C7, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, M6A 3B4, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0C1, Canada
Clinique IMD
Montreal, Quebec, H3H1E3, Canada
Changzhou No 2 Peoples Hospital
Changzhou, 213018, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510261, China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510655, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
Vojenska nemocnice Brno
Brno, 636 00, Czechia
Gastroenterologie, s.r.o., Hradec Kralove
Hradec Kralova, 500 02, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
Fakultni Nemocnice Ostrava
Ostrava-Poruba, 708 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00, Czechia
Fakultni Thomayerova nemocnice
Prague, 14000, Czechia
Aarhus University Hospital
Aarhus C, 8200, Denmark
Sydvestjysk Sygehus
Esbjerg, 6700, Denmark
NAU New Aalborg University Hospital
Gistrup, 9260, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Nordsjaellands Hospital, Hillerod
Hilleroed, 3400, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Bispebjerg Hospital
København NV, 2400, Denmark
Odense UH og Svendberg sygehus
Odense C, 5000, Denmark
CHU Amiens Picardie
Amiens, 80000, France
Clermont Ferrand University Hospital
Clermont-Ferrand, 63000, France
Institut Prive MICI Clinique des Cedres
Échirolles, 38130, France
Aphm - Hopital Nord
Marseille, 13015, France
CHU Nantes - Hotel Dieu
Nantes, 44000, France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200, France
CHU Nimes
Nîmes, 30900, France
Aphp Hopital Saint Antoine
Paris, 75012, France
Hospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU de Reims
Reims, 51100, France
Centre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy, 54511, France
GASTRO-Studien
Berlin, 10825, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, 12203, Germany
Universitatsklinikum Erlangen
Erlangen, 91054, Germany
Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich
Grevenbroich, 41515, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105, Germany
St. Marien und St. Annastiftskrankenhaus
Ludwigshafen am Rhein, 67067, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Klinikum rechts der Isar der TU Munchen
München, 81675, Germany
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Semmelweis Egyetem 1
Budapest, 1082, Hungary
Semmelweis Egyetem 2
Budapest, 1083, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Endomedix
Budapest, 1139, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136, Hungary
Clinexpert Gyongyos Kft
Gyöngyös, 3200, Hungary
Szegedi Tudomanyegyetem
Szeged, 6725, Hungary
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano
Bolzano, 39100, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, 16132, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Ospedale Mauriziano Torino
Torino, 10128, Italy
Maastricht UMC
Maastricht, 6229 HX, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC, Netherlands
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, 85 229, Poland
Centrum Medyczne Plejady
Krakow, 30363, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Centrum Medyczne 'Medyk' Sp. z o.o. K.
Rzeszów, 35-326, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, 87 100, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Medical Network Sp z o o
Warsaw, 04 501, Poland
FNsP F. D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Cliniq s.r.o.
Bratislava, 811 09, Slovakia
ENDOMED s.r.o
Košice, 040 13, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34, Slovakia
GASTRO I. s.r.o.
Prešov, 080 01, Slovakia
Gastro LM s.r.o.
Prešov, 080 01, Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 12, Slovakia
Hosp. Gral. Univ. Dr. Balmis
Alicante, 03010, Spain
Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Arquitecto Marcide
Ferrol, 15405, Spain
Hosp. Univ. Dr. Josep Trueta
Girona, 17007, Spain
Hosp. Univ. de Torrejon
Madrid, 28850, Spain
Hosp. de Navarra
Navarra, 31008, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Linkoping University Hospital
Linköping, 58185, Sweden
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Mölndal, 431 30, Sweden
Ersta sjukhus
Stockholm, 116 30, Sweden
Sodersjukhuset
Stockholm, 118 83, Sweden
Karolinska Universitetssjukhuset
Stockholm, 171 76, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Barts Health NHS Trust
Greater London, E1 2AJ, United Kingdom
London North West University Healthcare NHS Trust
Greater London, NW10 7NS, United Kingdom
West Middlesex University Hospital
Iselworth, TW7 6AF, United Kingdom
University College London Hospitals Nhs Foundation Trust
London, NW1 2PG, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Chelsea And Westminster Hospital
London, SW10 9NH, United Kingdom
Imperial College London
London, W120HS, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UQ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2026
First Posted
March 30, 2026
Study Start
April 21, 2026
Primary Completion (Estimated)
November 15, 2028
Study Completion (Estimated)
December 11, 2030
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.