A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Anaheim, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07577843
Phase
PHASE3
Status
Recruiting
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Conditions

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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

Key Dates

Start date
May 22, 2026
Status verified
Jun 2026
Primary completion
Jun 12, 2028
Completion
Jul 12, 2030

Study Design

Enrollment
460 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 treatment phase (Week 48) and who may 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 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 double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.

Primary Outcome Measure

Co-Primary: Percentage of Participants with Clinical Remission at Week 48 [ Time Frame: At Week 48 ]

Central Contacts

Locations (4)

FacilityCityStateZIP
Clinnova ResearchAnaheimCalifornia92805
Peak Gastroenterology AssociatesColorado SpringsColorado80907
GCP Clinical ResearchTampaFlorida33609
New York Gastroenterology AssociatesNew YorkNew York10075

Find similar trials in Anaheim, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Clinnova Research· Anaheim, CAPeak Gastroenterology Associates· Colorado Springs, COGCP Clinical Research· Tampa, FLNew York Gastroenterology Associates· New York, NY

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