JNJ-78934804 for Ulcerative Colitis
(DUET ENCORE-UC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for people with moderately to severely active ulcerative colitis, diagnosed at least 12 weeks ago. Participants must have ongoing symptoms and signs of inflammation on colon exam, and must have not responded well or couldn't tolerate previous standard treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive induction doses at Weeks 0, 4, and 8 followed by maintenance doses every 4 weeks starting at Week 12. Rescue doses are given at Weeks 16, 20, and 24 if needed.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension (optional)
Participants who benefit from the study intervention may continue treatment in the long-term extension phase
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares a new drug called JNJ-78934804 to an existing medication, guselkumab, over 48 weeks to see which works better and is safer for treating moderate to severe ulcerative colitis.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
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