Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05636293
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ritlecitinib — DRUG
    200mg Ritlecitinib
  • Placebo — DRUG
    Placebo
  • Gluten — OTHER
    10g of gluten

Study Details

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

Key Dates

Start date
Mar 1, 2023
Status verified
Apr 2026
Primary completion
Dec 9, 2025
Completion
Apr 9, 2026

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ritlecitinib
    10g gluten + 200mg of Ritlecitinib
  • Placebo Comparator: Placebo
    10g gluten + placebo

Primary Outcome Measure

Change in Small Intestinal Histology based on Vh:Cd ratio [ Time Frame: Through study completion, average of 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
Massachusetts General Hospital· Boston, MA

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