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
2 countries
11
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
11 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
May 8, 2026
May 1, 2026
2.6 years
March 23, 2026
May 7, 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 (11)
Clinnova Research
Anaheim, California, 92805, United States
TLC Clinical Research Inc
Los Angeles, California, 90048, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157-6575, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
London Digestive Disease Institute
London, Ontario, N6K 1M6, Canada
Clinique IMD
Montreal, Quebec, H3H1E3, Canada
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
May 8, 2026
Record last verified: 2026-05
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.