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Recruiting

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

NCT07499232 · Janssen Research & Development, LLC
In plain English

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Official title
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
About this study
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 criteria
Inclusion criteria: * 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: 1. a minimum score of 1 for the component of "size of ulcers" AND 2. 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 Exclusion criteria * 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
Study design
Enrollment target: 530 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-21
Estimated completion: 2030-12-11
Last updated: 2026-06-05
Interventions
Drug: GuselkumabDrug: Risankizumab
Primary outcomes
  • Number of Participants with Deep Remission at Week 52 (At Week 52)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (30)
Digestive Health Specialists of the SoutheastRecruiting
Dothan, Alabama, United States
Clinnova ResearchRecruiting
Anaheim, California, United States
United GastroenterologistsRecruiting
Los Alamitos, California, United States
TLC Clinical Research IncRecruiting
Los Angeles, California, United States
Hoag Memorial HospitalSuspended
Newport Beach, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Sanchez Clinical Research, IncRecruiting
Miami, Florida, United States
GCP Clinical ResearchRecruiting
Tampa, Florida, United States
Cotton-O'Neil Clinical Research CenterRecruiting
Topeka, Kansas, United States
Westchester Putnam GastroenterologyRecruiting
Carmel, New York, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
Charlotte Gastroenterology and Hepatology, PLLCRecruiting
Charlotte, North Carolina, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
Digestive Disease Specialists IncRecruiting
Oklahoma City, Oklahoma, United States
Frontier Clinical ResearchRecruiting
Uniontown, Pennsylvania, United States
Palmetto Primary and Specialty Care Physicians, CharlestonRecruiting
Summerville, South Carolina, United States
Southern Star Research Institute, LLCRecruiting
San Antonio, Texas, United States
GIRI Gastrointestinal Research InstituteRecruiting
Vancouver, British Columbia, Canada
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
Taunton Surgical CentreRecruiting
Oshawa, Ontario, Canada
Toronto Immune and Digestive Health Institute IncRecruiting
Toronto, Ontario, Canada
Clinique IMDRecruiting
Montreal, Quebec, Canada
The Sixth Affiliated Hospital Sun Yat sen UniversityRecruiting
Guangzhou, China
Sydvestjysk SygehusRecruiting
Esbjerg, Denmark
Herlev HospitalRecruiting
Herlev, Denmark
Sahlgrenska Universitetssjukhuset, Mölndal SjukhusRecruiting
Mölndal, Sweden
Ersta sjukhusRecruiting
Stockholm, Sweden
Karolinska UniversitetssjukhusetRecruiting
Stockholm, Sweden
Barts Health NHS TrustRecruiting
Greater London, United Kingdom
London North West University Healthcare NHS TrustRecruiting
Greater London, United Kingdom
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · TrialPath