Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac… (NCT05636293) | Clinical Trial Compass
CompletedPhase 2
Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission
United States62 participantsStarted 2023-03-01
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male and/or female subjects (including Women of Childbearing Potential (WOCBP)) ≥18 years to ≤75 years of age at the time of informed consent
✓. Have a body mass index ≥17 to \<40 (and a body weight \>45 kg at the Screening Visit).
✓. 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.
✓. 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 \</= 2 times the upper limit of normal), and (as determined at time of screening endoscopy) negative histology (Marsh 0, 1 or 2).
✓. Be HLA-DQ2.5 and/or HLA-DQ8 positive, as assessed at screening. If subjects have already been genotyped, then results from previous testing may be used in lieu of genotyping at screening.
✓. Must obtain negative SARS-CoV-2 test result (molecular diagnostic such as RT-PCR or RT-qPCR at the discretion of the investigator) at the screening visit and both timepoints prior to endoscopy (day 1 \&15).
✓. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
✓. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion criteria
✕
What they're measuring
1
Change in Small Intestinal Histology based on Vh:Cd ratio
Timeframe: Through study completion, average of 1 year.
2
Patient Reported Outcome Surveys (CeD PRO survey evaluation)
Timeframe: Through study completion, average of 1 year.
. 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).
✕. 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.
✕. Subjects considered in imminent need for surgery or with elective surgery scheduled to occur during the study
✕. Have a positive or borderline positive IgA anti-tissue transglutaminase serology at Screening (defined as \>/= 2 times the upper limit of normal).
✕. Have Marsh 3a-c determined by pathology at Screening Endoscopy
✕. A diagnosis of any other inflammatory gastrointestinal disorder
✕. Ongoing immunosuppression or receive any treatment within 3 months the starting of the trial that might alter T cell repertoire or phenotype.
✕. Has a confirmed history of a SARS-CoV-2 infection within the previous 2 months of the screening visit.