NCT07577856
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting
PHASE3Ages 18+InterventionalTreatmentJanssen Research & Development, LLC
~644 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:JNJ-78934804Guselkumab
At a glance
Recruiting sites
63 of 63 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants in Clinical Remission at Week 48
Measured over At Week 48
Conditions
Where it's being run
63 sites across 23 statesJapan14
Israel10
Turkey (Türkiye)7
Ontario4
Malaysia4
California3
Australia3
Florida2
Study leadership
- Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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
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
Has a history of or ongoing chronic or recurrent infectious disease
Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
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
What this trial measures
- Percentage of Participants in Clinical Remission at Week 48At Week 48
Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.