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Janus Kinase (JAK) Inhibitor
Ritlecitinib for Celiac Disease
Phase 2
Recruiting
Led By Alessio Fasano, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have well controlled biopsy-proven CeD, compliant with a GFD for ≥6 months preceding Screening, with resolution of CeD symptoms, normalization of CeD serology, and negative histology (Marsh 0, 1 or 2)
Have a body mass index ≥17 to <40 (and a body weight >45 kg at the Screening Visit)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 1 year.
Awards & highlights
Study Summary
This trial is testing a drug to treat celiac disease in HLA-DQ2.5 & DQ8+ people aged 18-75 who are gluten-free for 6+ months & have inactive disease.
Who is the study for?
Adults aged 18-75 with confirmed inactive celiac disease, on a gluten-free diet for at least 6 months, and positive for HLA-DQ2.5 or HLA-DQ8 can join this trial. They must not drink too much grapefruit juice, agree to contraception if applicable, avoid strenuous exercise before visits, have no recent surgeries or need for upcoming surgery, and test negative for SARS-CoV-2.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Ritlecitinib in people with celiac disease who are in remission. Participants will either receive Ritlecitinib plus gluten or a placebo plus gluten to see how well they tolerate the reintroduction of gluten into their diet.See study design
What are the potential side effects?
Potential side effects from Ritlecitinib may include immune system changes leading to increased infection risk, possible liver issues indicated by blood tests changes, headaches, nausea and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have celiac disease, follow a strict gluten-free diet for 6+ months, and my tests show improvement.
Select...
My BMI is between 17 and 40, and I weigh more than 45 kg.
Select...
I have celiac disease, follow a strict gluten-free diet for 6+ months, and my tests show improvement.
Select...
I agree to prevent pregnancy during the trial.
Select...
I am positive for HLA-DQ2.5 or HLA-DQ8.
Select...
I am between 18 and 75 years old.
Select...
I am positive for HLA-DQ2.5 or HLA-DQ8.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Small Intestinal Histology based on Vh:Cd ratio
Patient Reported Outcome Surveys (CeD PRO survey evaluation)
Secondary outcome measures
Changes in Small Intestinal Histology of intraepithelial lymphocytes (IELs)
Serology
Other outcome measures
Assess changes from Baseline in gluten-specific T cells in blood.
Assess correlation between gluten-specific blood T cells and standard CeD histological assessments.
Changes in gluten-specific T cells in small intestinal biopsies
+11 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: RitlecitinibActive Control2 Interventions
10g gluten + 200mg of Ritlecitinib
Group II: PlaceboPlacebo Group2 Interventions
10g gluten + placebo
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,451 Total Patients Enrolled
4 Trials studying Celiac Disease
610 Patients Enrolled for Celiac Disease
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,996 Total Patients Enrolled
3 Trials studying Celiac Disease
52,133 Patients Enrolled for Celiac Disease
Alessio Fasano, MDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
1,311 Total Patients Enrolled
1 Trials studying Celiac Disease
500 Patients Enrolled for Celiac Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to not do hard exercise and will stay hydrated during the study.You have a positive or borderline positive blood test for a certain type of antibody called IgA anti-tissue transglutaminase.I have been diagnosed with an inflammatory bowel condition.You have had strong or long-lasting symptoms after eating gluten.You should not drink more than 8 ounces of grapefruit juice per day while participating in the study.I agree to avoid hard exercise and stay hydrated during the study.I tested negative for COVID-19 before my screening and endoscopy appointments.I have celiac disease, follow a strict gluten-free diet for 6+ months, and my tests show improvement.I agree to use birth control to prevent pregnancy during the study.I have no history of untreated TB or I'm not currently being treated for TB.I haven't taken any medication in the last 3 months that affects my immune system.I had COVID-19 within the last 2 months.My BMI is between 17 and 40, and I weigh more than 45 kg.I have celiac disease, follow a strict gluten-free diet for 6+ months, and my tests show improvement.I agree to prevent pregnancy during the trial.I am positive for HLA-DQ2.5 or HLA-DQ8.You have been diagnosed with Marsh 3a-c by a doctor during a screening endoscopy.I have not had any abdominal or pelvic surgery in the last 3 months.I need surgery soon or have it scheduled during the study period.You have tested positive for HIV, Hepatitis B, or Hepatitis C during screening.Your body mass index (BMI) is between 17 and 40, and you weigh at least 45 kilograms.I am between 18 and 75 years old.You need to have a negative COVID-19 test before the screening visit and before two specific endoscopy appointments.I am positive for HLA-DQ2.5 or HLA-DQ8.
Research Study Groups:
This trial has the following groups:- Group 1: Ritlecitinib
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Celiac Disease Patient Testimony for trial: Trial Name: NCT05636293 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial still open?
"This clinical trial seeks 30 adults, aged 18 to 75, with a diagnosis of celiac disease. Eligible participants must have HLA-DQ2.5 and/or DQ8 genetics, demonstrate well controlled symptoms due to biopsy confirmed CeD compliant with a GFD for at least 6 months prior to screening (including normalization of serology), obtain negative results from SARS-CoV-2 testing (molecular diagnostic such as RT-PCR or RTqPCR) twice before endoscopy visits, read and sign an informed consent document, abstain from strenuous physical activity in the week leading"
Answered by AI
Has the FDA granted a stamp of approval for Ritlecitinib?
"The current data on Ritlecitinib's safety has been sufficient to rate this drug a 2 due its phase 2 status, which means there is evidence of security but no supporting research regarding efficacy."
Answered by AI
Is eligibility for this clinical trial limited to individuals aged 45 or younger?
"Patients between 18 and 75 years old are eligible for this trial. For younger participants, there are 12 other studies available while 26 trials exist for individuals over 65."
Answered by AI
How many subjects are enrolled in this research endeavor?
"Affirmative. The clinicaltrials.gov website attests that this trial is still in the process of recruitment and was originally posted on March 1st, 2023 with its most recent update taking place on March 19th, 2023. This study requires 30 participants to be recruited from a single medical centre."
Answered by AI
Are individuals able to enroll in this trial at the present time?
"According to information on clinicaltrials.gov, this investigation is actively recruiting test subjects. The trial was initially posted in March 1st 2023 and has since been updated as recently as the 19th of that same month."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I currently work in clinical research at BMC, specifically focused on lung cancer. I want to do my part in helping those suffering from celiac disease. My father and I have been gluten free for the past ~10 years after being diagnosed with celiac disease and I am looking forward to helping in any way I can!
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the screening visit and what does it consist of? If I am found to be eligible, how long does the study last, and how many visits are included? Is there any compensation for the study?
PatientReceived 1 prior treatment
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