Combination Therapy for Ulcerative Colitis
(DUET-UC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new drug, JNJ-78934804, compared to two existing treatments, guselkumab and golimumab (both immunotherapies), for individuals with ulcerative colitis who have not responded to current advanced therapies. Participants will receive one of these treatments or a placebo to determine which best alleviates symptoms. This trial may suit those with moderately to severely active ulcerative colitis for at least three months who have not responded to previous treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in ulcerative colitis treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In previous studies, guselkumab has demonstrated a strong safety record for treating ulcerative colitis. While it has some side effects, they are typical for this type of medication. Long-term research supports its safety for individuals with moderately to severely active ulcerative colitis.
Golimumab is another well-studied treatment option. Safety data from over a thousand patients indicate it is generally well-tolerated. The FDA has approved it for treating ulcerative colitis, confirming its safety for use.
For JNJ-78934804, limited data is available as it remains in the trial phase. Researchers are closely monitoring its effects. Since the study compares it to guselkumab and golimumab, they likely anticipate a similar safety profile. However, the complete picture remains unclear until more data emerges.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for ulcerative colitis because they offer new mechanisms of action that differ from current therapies. Golimumab and Guselkumab are biologics that target specific proteins involved in inflammation—Golimumab blocks tumor necrosis factor-alpha (TNF-alpha) while Guselkumab inhibits interleukin-23 (IL-23). Meanwhile, JNJ-78934804 is a novel agent being tested in different doses, adding another layer of potential treatment options. These approaches might provide more targeted relief with potentially better outcomes for those who don't respond well to existing treatments like 5-aminosalicylic acids, corticosteroids, and other biologics.
What evidence suggests that this trial's treatments could be effective for ulcerative colitis?
Research shows that guselkumab, which participants in this trial may receive, may help treat ulcerative colitis. In one study, 56.1% of patients taking guselkumab experienced clinical remission, compared to only 21.4% of those taking a placebo. Golimumab, another treatment option in this trial, also proved effective, with 57% of patients staying in remission after starting treatment. Early research suggests that the new treatment, JNJ-78934804, might control the disease better when used alongside other therapies than when used alone. While the effectiveness of JNJ-78934804 is still under investigation, early results are promising.34678
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 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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo, guselkumab, golimumab, or JNJ-78934804 subcutaneously. Participants with inadequate response may be escalated to an active treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of clinical remission and adverse events.
Long-term extension
Participants who are eligible and willing may continue the study intervention they are receiving at Week 44.
What Are the Treatments Tested in This Trial?
Interventions
- Golimumab
- Guselkumab
- JNJ-78934804
- Placebo
Trial Overview
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.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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.
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.
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.
Golimumab is already approved in European Union, United States, Canada for the following indications:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
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
Published Research Related to This Trial
Citations
Two‐year effectiveness and safety of golimumab in ...
Few data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis. No data have been reported on real‐world continuous clinical response.
Effectiveness of golimumab in patients with ulcerative colitis
Golimumab treatment was associated with a sustained reduction of symptoms and clinical response in approximately 30% of patients. [ ...
An Efficacy and Safety Study of Golimumab (CNTO 148) in ...
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
SIMPONI® (golimumab) Clinical Trials Information for HCPs
PURSUIT: Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis.
U.S. FDA approves SIMPONI® (golimumab) for the ...
Among patients treated with SIMPONI® who were in clinical remission at Week 6, 57% maintained clinical remission of symptoms at Week 54. Safety ...
Simponi - accessdata.fda.gov
safety data in 1233 SIMPONI-treated patients with ulcerative colitis from 3 pooled, randomized, double-blind, controlled Phase 2/3 trials are also described ...
Safety data tables - NCBI - NIH
Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a ...
SIMPONI® (golimumab) Treatment®
SIMPONI® (golimumab) is for RA, PsA, AS and UC treatment. See full Prescribing & Safety info including Boxed Warning.
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