What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis, particularly those involving immune modulation or anti-inflammatory effects, have several known side effects. Biologics such as infliximab, adalimumab, and golimumab can cause infections, infusion reactions, and potential development of antibodies against the drug. Small molecules like tofacitinib, a Janus kinase inhibitor, are associated with risks such as herpes zoster infection and thromboembolism. Other side effects across these treatments may include headache, nausea, and increased risk of certain cancers. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several biologic agents and small molecules for the treatment of Ulcerative Colitis, focusing on immune modulation and anti-inflammatory effects. Notable approvals include anti-TNF agents like infliximab and adalimumab, which target tumor necrosis factor-alpha to reduce inflammation. Anti-integrin agents such as vedolizumab inhibit the migration of immune cells to the gut. Additionally, anti-IL-12/23 agents like ustekinumab target interleukins involved in the inflammatory process. These therapies have shown efficacy in managing moderate to severe UC, particularly in patients who have not responded to conventional treatments.

What other types of research exist?

Promising novel alternatives to JNJ-78934804 for ulcerative colitis patients include guselkumab, golimumab, and AJM300. Guselkumab and golimumab are biologic agents targeting specific immune pathways, while AJM300 is an oral antagonist of the α4 integrin subunit, showing efficacy in clinical trials for active ulcerative colitis.

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Monoclonal Antibodies

Combination Therapy for Ulcerative Colitis (DUET-UC Trial)

Phase 2

Waitlist Available

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

Must not have

Extent of inflammatory disease limited to the rectum

Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Summary

This trial is testing a new medication, JNJ-78934804, for patients with severe ulcerative colitis who haven't had success with other treatments. The medication aims to reduce inflammation by targeting the immune system.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ulcerative colitis for at least 3 months.

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My ulcerative colitis is moderate to severe, according to the Mayo Score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My inflammation is only in my rectum.

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I have been diagnosed with a specific type of colitis or Crohn's disease.

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I have severe widespread inflammation in my colon.

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I have a history of or currently have a chronic infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Clinical Remission at Week 48

Secondary study objectives

Laboratory Parameters Over Time

Percentage of Participants with Adverse Events (AEs)

Percentage of Participants with Antibodies to Golimumab

+15 more

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

~6080

Golimumab

2014

Completed Phase 4

~3610

0 / 6Eligibility criteria met

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.