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PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing JNJ-78934804 for Colitis, Ulcerative

This study wants to assess how well JNJ-78934804 works (how well it works) 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).

Official registry: https://clinicaltrials.gov/study/NCT07577856 · Janssen Research & Development, LLC · enrollment listed as 644

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are JNJ-78934804, or Guselkumab. The registry lists allocation as randomized. This study wants to assess how well JNJ-78934804 works (how well it works) 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).

They plan to enroll about 644 people at 318 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: JNJ-78934804, Guselkumab

Primary outcome (registry wording): Percentage of Participants in Clinical Remission at Week 48

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

318 listed

+ 288 sites outside the US on the same record

Related recruiting trials in this snapshot

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Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies.

NCT06006039 · Official ClinicalTrials.gov record · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

FAQ about this NCT record

Is NCT07577856 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07577856?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07577856?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary