Compares JNJ-78934804 with guselkumab in ulcerative colitis
Tests JNJ-78934804 against guselkumab in adults with moderately to severely active ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
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, San Antonio, San Diego, Scottsdale, Summerville, Sun City, Suwanee, Tacoma, Tampa, Tyler, Uniontown, and Webster, United StatesSee the 30 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
- Southern Star Research Institute, LLCSan Antonio, 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
- Frontier Clinical ResearchUniontown, 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
- NCT07577856EU 2026-525923-26-00
- 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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).Read full original descriptionShow less
78934804UCO3001: 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 Ulcerative Colitis
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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Inclusion: Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC; Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy; An endoscopy subscore >=2 as obtained during central review of the screening video endoscopy; Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies.
Exclusion: Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab; Has a history of or ongoing chronic or recurrent infectious disease; Isolated proctitis (UC limited to the rectum only or to less than [<] 20 centimeter [cm] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis; Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD; Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention.