Compares JNJ-78934804 with guselkumab in people with Crohn's disease
Tests JNJ-78934804 against guselkumab in adults with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Anaheim, Chapel Hill, Chula Vista, Colorado Springs, Cordova, Crestview Hills, Farmington Hill, Lafayette, Lakewood Rch, Lee's Summit, Los Alamitos, Mentor, Metairie, Miami, New York, Oklahoma City, Orlando, Portland, Richmond, Rochester, San Diego, Scottsdale, Summerville, Sun City, Suwanee, Tacoma, Tampa, Tyler, and Webster, United StatesSee the 29 sites
- Phase
- Phase 3
Where in United States
- Clinnova ResearchAnaheim, United StatesTaking people
- University of North Carolina HospitalChapel Hill, United StatesTaking people
- Gastro SB ClinicChula Vista, United StatesTaking people
- Peak Gastroenterology AssociatesColorado Springs, United StatesTaking people
- Gastro OneCordova, United StatesTaking people
- Tri-State Gastroenterology AssocCrestview Hills, United StatesTaking people
- Michigan Center of Medical ResearchFarmington Hill, United StatesTaking people
- Gastroenterology Clinic of AcadianaLafayette, United StatesTaking people
- Florida Research Center Inc.Lakewood Rch, United StatesTaking people
- GIA Kansas CityLee's Summit, United StatesTaking people
- United Medical DoctorsLos Alamitos, United StatesTaking people
- Great Lakes Gastroenterology Research, LLCMentor, United StatesTaking people
- GIA MetairieMetairie, United StatesTaking people
- Sanchez Clinical Research ,IncMiami, United StatesTaking people
- New York Gastroenterology AssociatesNew York, United StatesTaking people
- Digestive Disease Specialists, IncOklahoma City, United StatesTaking people
- Endoscopic Research, IncOrlando, United StatesTaking people
- The Oregon ClinicPortland, United StatesTaking people
- GIA RichmondRichmond, United StatesTaking people
- GIA RochesterRochester, United StatesTaking people
- Medical Associates Research Group, Inc.San Diego, United StatesTaking people
- Mayo ClinicScottsdale, United StatesTaking people
- Palmetto Primary and Specialty Care Physicians, CharlestonSummerville, United StatesTaking people
- GIA Sun CitySun City, United StatesTaking people
- Atlanta Gastroenterology SpecialistsSuwanee, United StatesTaking people
- GI Alliance TacomaTacoma, United StatesTaking people
- GCP Clinical ResearchTampa, United StatesTaking people
- Tyler Research Institute, LLCTyler, United StatesTaking people
- GIA WebsterWebster, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07577843EU 2026-525922-39-00
- Record updated
- 3 November 2026
- Original description
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine).Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine).
Inclusion: Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD; Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP); Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria; Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies.
Exclusion: Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study; Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention; Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC; Presence of draining (that is, functioning) stoma or ostomy; Currently has or is suspected of having an abscess.