Ritlecitinib for Celiac Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing Ritlecitinib to see if it can help adults with celiac disease in remission avoid symptoms when they eat gluten. Participants will take either the drug or a non-active substance and eat a small amount of gluten regularly. The drug aims to block immune signals that cause inflammation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on ongoing immunosuppression or treatments that might alter T cell function, you may not be eligible to participate.
How does the drug Ritlecitinib differ from other treatments for celiac disease?
Who Is on the Research Team?
Alessio Fasano, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults aged 18-75 with confirmed inactive celiac disease, on a gluten-free diet for at least 6 months, and positive for HLA-DQ2.5 or HLA-DQ8 can join this trial. They must not drink too much grapefruit juice, agree to contraception if applicable, avoid strenuous exercise before visits, have no recent surgeries or need for upcoming surgery, and test negative for SARS-CoV-2.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 10g gluten + 200mg of Ritlecitinib or placebo daily for 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ritlecitinib
Ritlecitinib is already approved in European Union, United States for the following indications:
- Severe alopecia areata
- Severe alopecia areata
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University