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

Part of paid clinical trials in Anaheim, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07577856
Phase
PHASE3
Status
Recruiting
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Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-78934804 — DRUG
    JNJ-78934804 will be administered subcutaneously.
  • Guselkumab — DRUG
    Guselkumab will be administered subcutaneously.

Study Details

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).

Key Dates

Start date
May 23, 2026
Status verified
Jun 2026
Primary completion
Aug 11, 2028
Completion
Oct 30, 2030

Study Design

Enrollment
644 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JNJ-78934804
    Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
  • Active Comparator: Guselkumab
    Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.

Primary Outcome Measure

Percentage of Participants in Clinical Remission at Week 48 [ Time Frame: At Week 48 ]

Central Contacts

Locations (5)

FacilityCityStateZIP
Clinnova ResearchAnaheimCalifornia92805
Peak Gastroenterology AssociatesColorado SpringsColorado80907
GCP Clinical ResearchTampaFlorida33609
New York Gastroenterology AssociatesNew YorkNew York10075
Southern Star Research Institute, LLCSan AntonioTexas78229

Find similar trials in Anaheim, CA

By research site
Clinnova Research· Anaheim, CAPeak Gastroenterology Associates· Colorado Springs, COGCP Clinical Research· Tampa, FLNew York Gastroenterology Associates· New York, NYSouthern Star Research Institute, LLC· San Antonio, TX

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