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RecruitingPhase 3

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

Janssen Research & Development, LLC · NCT07577856

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
644
US sites recruiting
24
Study start
May 23, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: JNJ-78934804; Guselkumab

Conditions: Colitis, Ulcerative

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com
A Study of JNJ-78934804 in Participants With Moderately to… (NCT07577856) | Bored Studies