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Monoclonal Antibodies

Combination Therapy for Ulcerative Colitis (DUET-UC Trial)

Phase 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
Moderately to severely active UC as assessed by the modified Mayo Score
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

DUET-UC Trial Summary

This trial will compare the effectiveness of a new drug, JNJ-78934804, to existing treatments for ulcerative colitis.

Who is the study for?
This trial is for adults with moderate to severe ulcerative colitis who haven't responded well to at least one biologic or similar treatment. Participants must have been diagnosed with UC for a minimum of three months and, if female and able to have children, agree to follow specific contraception guidelines.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of JNJ-78934804 against guselkumab and golimumab in patients whose ulcerative colitis hasn't improved with standard advanced therapies. It aims to see which treatment helps more.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, injection site reactions, infections due to lowered immunity, allergic responses, and possibly others not yet known as these are newer treatments being studied.

DUET-UC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ulcerative colitis for at least 3 months.
Select...
My ulcerative colitis is moderate to severe, according to the Mayo Score.

DUET-UC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Clinical Remission at Week 48
Secondary outcome measures
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Antibodies to Golimumab
Percentage of Participants with Antibodies to Guselkumab
+11 more

DUET-UC Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 6: JNJ-78934804 (Low-dose)Experimental Treatment1 Intervention
Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group II: Group 5: JNJ-78934804 (Mid-dose)Experimental Treatment1 Intervention
Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group III: Group 4: JNJ-78934804 (High-dose)Experimental Treatment1 Intervention
Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group IV: Group 3: GolimumabExperimental Treatment1 Intervention
Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group V: Group 2: GuselkumabExperimental Treatment1 Intervention
Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Group VI: Group 1: PlaceboPlacebo Group1 Intervention
Participants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Golimumab
2014
Completed Phase 4
~3480

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ulcerative Colitis (UC) often involve biologic agents that target specific components of the immune system to reduce inflammation. Infliximab, for example, is an anti-TNF (tumor necrosis factor) agent that blocks TNF, a cytokine involved in systemic inflammation. Vedolizumab targets integrin α4β7, inhibiting the migration of inflammatory cells to the gut. The combination therapy of guselkumab and golimumab, as studied in the trial JNJ-78934804, likely involves targeting interleukin pathways and TNF, respectively, to modulate the immune response and reduce inflammation. These mechanisms are crucial for UC patients as they help to control symptoms, achieve remission, and prevent disease progression.

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,544 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,122 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis

Media Library

Golimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05242484 — Phase 2
~189 spots leftby May 2025
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