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
- Adelaide, Camperdown, Clayton, Kurraba Point, Macquarie Island, Murdoch, New Lambton, South Brisbane, and West Melbourne, AustraliaSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to, or could not tolerate, earlier approved medicines.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Ulcerative colitis diagnosed at least 12 weeks before screening, with endoscopy and biopsy findings. The disease must be moderately to severely active: modified Mayo score of 5 to 9 and a Mayo endoscopy subscore of 2 or higher.
- Earlier treatment
- Must have had an inadequate first response, loss of response, or intolerance to earlier approved systemic therapies. Cannot have had an inadequate response, loss of response, allergy or intolerance to guselkumab or golimumab.
Main reasons for not taking part
- Inflammation only in the rectum (isolated proctitis)
- Other types of colitis, such as indeterminate, microscopic, ischemic or Crohn's colitis
- Past or ongoing long-lasting or recurring infectious disease
- Pregnant, breastfeeding, or planning to become pregnant
- Planning to father a child during the trial or within 6 months after the last dose
Read by machine on 9 November 2026.
Where in Australia
- Banksia Trials SAAdelaide, AustraliaTaking people
- Royal Prince Alfred HospitalCamperdown, AustraliaTaking people
- Monash Medical CentreClayton, AustraliaTaking people
- SA Gastrointestinal ServicesKurraba Point, AustraliaTaking people
- Macquarie UniversityMacquarie Island, AustraliaTaking people
- Fiona Stanley HospitalMurdoch, AustraliaTaking people
- John Hunter HospitalNew Lambton, AustraliaTaking people
- Mater Misericordiae HospitalSouth Brisbane, AustraliaTaking people
- The Melbourne Gut Clinic Epworth HospitalWest Melbourne, AustraliaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.