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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

RecruitingPhase 3

A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion criteria:

* 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 criteria:

* 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

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 644 · Started: May 23, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07577856

Locations in the U.S.

CaliforniaClinnova Research, Anaheim
Gastro SB Clinic, Chula Vista
United Medical Doctors, Los Alamitos
Medical Associates Research Group, Inc., San Diego
ColoradoPeak Gastroenterology Associates, Colorado Springs
FloridaFlorida Research Center Inc., Lakewood Rch
Sanchez Clinical Research, Inc, Miami
GCP Clinical Research, Tampa
GeorgiaAtlanta Gastroenterology Specialists, Suwanee
KentuckyTri-State Gastroenterology Assoc, Crestview Hills
LouisianaGastroenterology Clinic of Acadiana, Lafayette
MichiganMichigan Center of Medical Research, Farmington Hills
New YorkNew York Gastroenterology Associates, New York
OhioGreat Lakes Gastroenterology Research, LLC, Mentor
OklahomaDigestive Disease Specialists Inc, Oklahoma City
OregonThe Oregon Clinic, Portland
TennesseeGastro One, Cordova
TexasSouthern Star Research Institute, LLC, San Antonio
Tyler Research Institute, LLC, Tyler
WashingtonGI Alliance Tacoma, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.