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
- Berlin, Dachau, Dresden, Erlangen, Frankfurt Am Main, Halle (Saale), Halle Saale, Hanover, Jena, Kassel, Kiel, Leipzig, Mannheim, Munich, Regensburg, Rostock, and Ulm, GermanySee the 21 sites
- Phase
- Phase 3
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- GASTRO-StudienBerlin, GermanyTaking people
- Gastroenterologie BerlinBerlin, GermanyTaking people
- Krankenhaus Waldfriede e.V.Berlin, GermanyTaking people
- Medizinisches Versorgungszentrum DachauDachau, GermanyTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyTaking people
- Studiengesellschaft BSF UG (haftungsbeschraenkt)Halle (Saale), GermanyTaking people
- Universitaetsklinikum Halle (Saale) AöRHalle Saale, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Universitaetsklinikum Jena KöRJena, GermanyTaking people
- Gastroenterologie OpernstrasseKassel, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Eugastro GmbHLeipzig, GermanyTaking people
- Heidelberg UniversityMannheim, GermanyTaking people
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking 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.