Combination Therapy for Crohn's Disease
(DUET-CD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new medication called JNJ-78934804 to see if it works better than two existing treatments for autoimmune conditions. The study will compare their effectiveness over several months.
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 Golimumab safe for treating Crohn's Disease?
How is the combination therapy for Crohn's disease with Golimumab, Guselkumab, and JNJ-78934804 different from other treatments?
This combination therapy is unique because it involves Golimumab, which is typically used for ulcerative colitis and not standard for Crohn's disease, and Guselkumab, which targets a different inflammatory pathway (interleukin-23) than traditional treatments. This approach may offer a novel option for patients who do not respond to standard anti-TNF (tumor necrosis factor) therapies.12567
What data supports the effectiveness of the drug combination therapy for Crohn's Disease?
Golimumab, one of the drugs in the combination, has been used off-label for difficult-to-treat Crohn's Disease cases, showing potential as a rescue medication. Additionally, adalimumab, a similar drug targeting tumor necrosis factor, has been effective in inducing and maintaining remission in Crohn's Disease patients, suggesting that similar drugs may also be beneficial.15689
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 Crohn's Disease who haven't had success with at least one biologic treatment. They must have been diagnosed at least 3 months prior and meet specific disease activity criteria. Women of childbearing age should comply with contraception requirements. Exclusions include a recent history of cancer, certain infections, or recent surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either JNJ-78934804, guselkumab, golimumab, or placebo subcutaneously. Participants with inadequate response may be escalated to an active treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension (optional)
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
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