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NCT05636293 · ClinicalTrials.gov registry record · Phase 2
Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission
A Phase 2 study of Celiac Disease, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05636293: Recruiting Phase 2 study of Celiac Disease, sponsored by Massachusetts General Hospital.
NCT05636293 is a Phase 2 study of Celiac Disease that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 40 participants, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05636293, a Phase 2 study of Celiac Disease, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Subjects include: aged 18 to 75 years, inclusive, have biopsy-confirmed disease that is clinically inactive as determined by negative celiac disease (CeD) serology and histology (determined via endoscopy at time of screening), have followed a gluten-free diet (GFD) for ≥6 months as reported by the subject, and be human leukocyte antigen (HLA)-DQ2.5 and/or HLA-DQ8 positive. Study involves the following randomized intervention; 10g gluten + 200mg of Ritlecitinib or placebo
Primary Outcome
Characterize the gluten-challenge induced changes in small intestine histology using standard for Celiac Disease histological assessments related to villus height to crypt depth ratio \[Vh:Cd\]
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ritlecitinib
- OTHER Gluten
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What NCT05636293 shows while recruiting
NCT05636293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05636293 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05636293 about?
NCT05636293 is a clinical study titled "Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission". Subjects include: aged 18 to 75 years, inclusive, have biopsy-confirmed disease that is clinically inactive as determined by negative celiac disease (CeD) serology and histology (determined via endoscopy at time of screening), have followed a gluten-free diet (GFD) for ≥6 months as reported by the s...
What is the current status of trial NCT05636293?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-03-01. Estimated completion is 2025-12-31.
What conditions does trial NCT05636293 study?
This clinical trial studies the following conditions: Celiac Disease.
What interventions are being tested in trial NCT05636293?
The interventions under investigation include: Placebo (DRUG), Ritlecitinib (DRUG), Gluten (OTHER).
Who is sponsoring clinical trial NCT05636293?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05636293 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Celiac Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05636293's enrollment target sits among peer trials
40 19th of 24 higher than 4 of 24 other Celiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Celiac Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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