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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

We are studying the inhibitory effects of the drug Ritlecitinib on inflammatory pathways in patients with celiac disease. This study will help us understand the efficacy of medicinal treatments in people with celiac disease.

7 visits over 15 weeks
Estimated Time Commitment
Any Sex/Gender, 18-75 years
May Be Eligible
Payment up to $2,050, Meals
May Be Offered
Survey, Blood draw, Injection or IV, Endoscopy, Medication, Office visit, Biopsy, Biosample (e.g., saliva, urine, or stool), Sedation, Personal health tracking
May Be Required
 
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Enrollment for this study is expected to close on Thursday, November 13, 2025

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. 

Principal Investigator

Alessio Fasano, MD

Massachusetts General Hospital

Public Profile

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

celiacresearch@mgh.harvard.edu
(617) 643-4366

Adults aged 18-75, healthy other than having biopsy-confirmed celiac disease, on a gluten-free diet for at least 6 months. 

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.

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


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. 

Massachusetts General Hospital
55 Fruit Street Boston, MA

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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.


ClinicalTrials.gov Identifier

NCT05636293


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.


Participating Institutions


Funding Source

  • Industry
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