Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Participants needed to advance a therapeutic treatment for celiac disease
Enrollment for this study is expected to close on Thursday, November 13, 2025
Overview
What we are studying
This clinical trial is being conducted in patients with biopsy-proven celiac disease placed on a gluten challenge (21 days of daily gluten consumption) to determine the effects of the drug Ritlecitnib on gluten induced symptoms and enteropathy. Additionally, patients will take a drug capsule (or placebo) for 21 days. A number of different blood and intestinal biomarkers will be collected via blood draws and small intestine endoscopies. The samples will be evaluated to see how they change in patients with celiac disease after a 21-day gluten challenge and consumption of Ritlecitinib (or placebo).
Why it is important
Currently, the only treatment for celiac disease is a strict, lifelong gluten-free diet. This study will help us understand and develop alternative treatment methods for patients with celiac disease.
What we hope to accomplish
The main goal of this study is to characterize the gluten-challenge induced changes in small intestine histology and the blood microbiome. Certain cells in the small intestine and the blood are activated as part of an immune response to gluten exposure. We hope to understand whether Ritlecitinib prevents these cells from activating. The results of this study will help us understand whether Ritlecitinib is a viable therapeutic option for patients with celiac disease.
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Principal Investigator
Project Contact
Click I Am Interested "I Am Interested" "I Am Interested" to get started. If you have questions, contact:
Victoria Kenyon
Clinical Research Project Manager
Who can participate
Adults aged 18-75, healthy other than having biopsy-confirmed celiac disease, on a gluten-free diet for at least 6 months.
Who cannot participate
Patients that are <18 or >75 years old, were not diagnosed via endoscopy, have recently had a major surgery, and/or have any other major health conditions such as other autoimmune diseases, gastrointestinal disorders (aside from celiac disease), or cancer.
What you may be asked to do
Participation involves 7 visits to Massachusetts General Hospital over a 15-week period. Study visits include collection of blood, urine, and stool, COVID-19 tests, genetic testing, 2 endoscopies, an electrocardiogram, a 21-day gluten challenge, daily consumption of the study drug (or placebo), and recording of symptoms in a symptom diary. These procedures are at no cost to the participants.
Project activities may include:
- Survey
- Blood draw
- Injection or IV
- Endoscopy
- Medication
- Office visit
- Biopsy
- Biosample (e.g., saliva, urine, or stool)
- Sedation
- Personal health tracking
Estimated Time Commitment
7 visits over 15 weeks
What You May Get
Payment will be provided on a visit-by-visit basis in accordance with the following payment schedule: $200 for Visit 1, $450 for Visit 2 (screening endoscopy), $200 for Visit 3, $200 for Visit 4, $400 for Visit 5, $450 for Visit 6 (endoscopy), and $150 for Visit 7 (follow up). Total compensation for completing the study is $2050.
Location
Massachusetts General Hospital
55 Fruit Street Boston, MA
Travel
- Parking reimbursed
- Accessible by public transportation
- Local travel reimbursed
- Out of state travel possibly reimbursed
Travel and Parking Details
You will be reimbursed for parking for each visit, and you will be given meal vouchers when you complete each visit.
Additional Information
Study Phase
Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.
Funding Source
- Industry