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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male and/or female subjects (including Women of Childbearing Potential (WOCBP)) ≥18 years to ≤75 years of age at the time of informed consent. 2. Have a body mass index ≥17 to <40 (and a body weight >45 kg at the Screening Visit). 3. Agree to make every effort to avoid pregnancy (see lifestyle outline below) from the time of signing the informed consent throughout the duration of the trial, if the subject is a woman of childbearing potential and sexually active with a non-sterilized male partner. 4. Have well controlled biopsy-proven CeD, compliant with a GFD for ≥6 months preceding Screening, with resolution of CeD symptoms, normalization of CeD serology (defined as
  • - Subjects who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must agree to use 2 methods of effective contraception (at least 1 highly effective method) throughout the study and for at least 28 days after the last dose of investigational product.
  • The investigator or his or her designee, in consultation with the subject, will confirm that the subject has selected 2 appropriate methods of contraception for the individual subject and his/her partner(s) from the list of permitted contraception methods (see below) and will confirm that the subject has been instructed in their consistent and correct use. At time points indicated in the Schedule of Activities, the investigator or designee will inform the subject of the need to use 2 methods of effective contraception (at least 1 highly effective method) consistently and correctly and document the conversation, and the subject's affirmation, in the subject's chart. In addition, the investigator or designee will instruct the subject to call immediately if 1 or both selected contraception methods are discontinued or if pregnancy is known or suspected in the subject or partner.
    • - Highly effective methods of contraception are those that, alone or in combination, result in a failure rate of less than 1% per year when used consistently and correctly (i.e., perfect use) and include the following: - Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
    • - Intrauterine device (IUD).
    • - Intrauterine hormone-releasing system (IUS).
    • - Bilateral tubal occlusion or tubal ligation.
    • - Vasectomized partner: Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual partner of the WOCBP and the absence of sperm has been confirmed.
    If not, an additional highly effective method of contraception should be used. The spermatogenesis cycle is approximately 90 days.
    • - Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral; intravaginal; transdermal.
    • - Progestogen-only hormone contraception associated with inhibition of ovulation: oral; injectable.
    • - Sexual abstinence: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention.
    The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
    • - Male condom or female condom: All sexually active male subjects must agree to prevent potential transfer to and exposure of partner(s) to drug through ejaculate by using a condom consistently and correctly, beginning with the first dose of investigational product and continuing for at least 28 days after the last dose of investigational product.
    Male subjects must refrain from donating sperm during the study and for 90 days after the last dose of investigational product.

    Exclusion Criteria:

    1. Have a history of gluten triggered acute symptoms (≤24 hours after gluten exposure), and/or severe symptoms (abdominal pain interfering with daily activities, diarrhea with >5 stools/day), and/or prolonged symptoms (duration >7 days). 2. A history of any abdominal or pelvic surgery <3 months before trial enrollment; prior surgery abdominal or pelvic surgery (e.g., cholecystectomy, appendectomy, and hysterectomy) are permitted if performed >3 months before trial enrollment. 3. Subjects considered in imminent need for surgery or with elective surgery scheduled to occur during the study. 4. Have a positive or borderline positive IgA anti-tissue transglutaminase serology at Screening (defined as >/= 2 times the upper limit of normal). 5. Have Marsh 3a-c determined by pathology at Screening Endoscopy. 6. A diagnosis of any other inflammatory gastrointestinal disorder. 7. Ongoing immunosuppression or receive any treatment within 3 months the starting of the trial that might alter T cell repertoire or phenotype. 8. Has a confirmed history of a SARS-CoV-2 infection within the previous 2 months of the screening visit. 9. Any history of either untreated or inadequately treated latent or active TB infection by Interferon Gamma Release Assay during screening or within 12 weeks prior to randomization, current treatment for active or latent TB infection or evidence of currently active TB by chest x-ray, residing with or frequent close contact with individual(s) with active TB. 10. Positive screening for HIV, Hepatitis B, Hepatitis C.

    Trial Details

    Trial ID:

    This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


    Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

    Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

    Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

    Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

    Phase 2
    Lead Sponsor

    The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

    Massachusetts General Hospital
    Principal Investigator

    The person who is responsible for the scientific and technical direction of the entire clinical study.

    Alessio Fasano, MD
    Principal Investigator Affiliation Massachusetts General Hospital
    Agency Class

    Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

    Other, Industry
    Overall Status Recruiting
    Countries United States

    The disease, disorder, syndrome, illness, or injury that is being studied.

    Celiac Disease
    Additional Details

    The investigators are proposing a double blind, placebo-controlled trial to establish safety and efficacy of ritlecitinib to prevent gluten-induced celiac enteropathy and symptoms in celiac disease (CeD) patients in remission. The results of this study will impact the therapeutic options in the future for individuals with CeD. Participants will take placebo capsule or ritlecitinib 200 mg capsule once per day. Both will be taken orally. All participants will take 10g gluten once per day, for a total of 21 days. Gluten will be taken orally by mixing the gluten powder into either hot chocolate or apple sauce. If participant unable to tolerate 10g of gluten daily, they will have the option to decrease to 5g daily after Day 3 of study.

    Arms & Interventions


    Active Comparator: Ritlecitinib

    10g gluten + 200mg of Ritlecitinib

    Placebo Comparator: Placebo

    10g gluten + placebo


    Drug: - Ritlecitinib

    200mg Ritlecitinib

    Drug: - Placebo


    Other: - Gluten

    10g of gluten

    Contact a Trial Team

    If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

    Massachusetts General Hospital, Boston, Massachusetts




    Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Site Contact

    Victoria Kenyon, MHA


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