A Study of Guselkumab in Adult Participants With Celiac Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of guselkumab in people with celiac disease. Guselkumab aims to reduce the immune system's harmful reaction to gluten. It has been previously tested for moderate to severe psoriasis.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
How is the drug Guselkumab different from other treatments?
Guselkumab is unique because it specifically targets the interleukin-23 (IL-23) pathway, which plays a key role in inflammatory processes, making it different from other treatments that may target broader immune pathways. This specificity can lead to more targeted treatment with potentially fewer side effects.12345
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?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous infusion of guselkumab or placebo every 4 weeks through Week 8, followed by subcutaneous injection at Week 12
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Guselkumab
- Placebo
Guselkumab is already approved in United States, European Union for the following indications:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active ulcerative colitis
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Moderately to severely active 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