Actively Recruiting
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Moderately to Severely Active Crohn's Disease
Led by Janssen Research & Development, LLC · Updated on 2026-06-08
460
Participants Needed
5
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a drug called JNJ-78934804 compared to guselkumab for people with moderately to severely active Crohn's disease, a serious and progressive condition affecting the intestines. This Phase 3 study focuses on how well these treatments work to achieve clinical and endoscopic remission by Week 48. The trial is sponsored by Janssen Research & Development, LLC and aims to provide new options for managing this long-term illness. Participants will be randomly assigned to receive either JNJ-78934804 or guselkumab. Both treatments involve induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting at Week 12. If needed, participants meeting rescue criteria will get additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, then continue maintenance doses every 4 weeks starting at Week 28. Those who complete the 48-week double-blind phase and may benefit from continued treatment may enter a long-term extension phase. During the study, participants will undergo various assessments, including endoscopic evaluations and clinical remission checks at Week 48. Researchers will monitor safety by tracking adverse events for up to about 3 years. Outcome measures also include corticosteroid-free remission, quality of life questionnaires, and sustained clinical remission evaluations. The total participation time includes the initial 48-week treatment phase with possible longer follow-up in the extension phase.
CONDITIONS
Brief Title
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Crohn's disease or fistulizing Crohn's disease established at least 12 weeks before screening with endoscopic and histopathology confirmation
- Moderately to severely active Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) score between 220 and 450
- Mean daily stool frequency of 4 or more, or mean daily abdominal pain score of 2 or more
- Moderately to severely active ileal and/or colonic Crohn's disease confirmed by central review of screening ileocolonoscopy
- History of inadequate response, loss of response, or intolerance to previously approved systemic therapies
You will not qualify if you...
- Diagnosis or clinical signs of ulcerative colitis, indeterminate colitis, microscopic colitis, or ischemic colitis
- Complications requiring intestinal surgery such as symptomatic bowel strictures or stenoses
- Presence of a functioning stoma or ostomy
- History of short bowel syndrome or missing more than 2 of 5 ileocolonic segments
- Medical conditions that affect the ability to assess response to treatment
- Current or suspected abscess
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive induction doses of the study drug at Weeks 0, 4, and 8 followed by maintenance doses every 4 weeks starting at Week 12. Participants who meet rescue criteria receive additional induction doses at Weeks 16, 20, and 24 followed by maintenance every 4 weeks starting at Week 28.
Visits at Weeks 0, 4, 8, 12, 16, 20, 24 and then every 4 weeks until Week 48
Duration - Up to approximately 3 years
Participants who complete the double-blind treatment phase and may benefit from continued intervention have the opportunity to enter this phase.
Visit schedule determined by investigator during extension phase
Trial Site Locations
Total: 5 locations
1
Clinnova Research
Anaheim, California, United States, 92805
Actively Recruiting
2
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
GCP Clinical Research
Tampa, Florida, United States, 33609
Actively Recruiting
4
New York Gastroenterology Associates
New York, New York, United States, 10075
Actively Recruiting
5
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Japan, 892-0843
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here