What is the mechanism of action of this treatment?

The primary treatment for Celiac Disease is a strict gluten-free diet, which eliminates the ingestion of gluten, thereby preventing the autoimmune response that damages the small intestine. Emerging treatments, such as Janus kinase (JAK) inhibitors like Ritlecitinib, work by blocking specific pathways involved in the inflammatory response. JAK inhibitors can potentially reduce the immune-mediated damage to the intestinal lining, offering an alternative for patients who do not fully respond to a gluten-free diet. This is significant for Celiac Disease patients as it provides a potential therapeutic option to manage symptoms and intestinal damage more effectively.

What side effects are associated with this type of intervention?

Common side effects of Janus kinase (JAK) inhibitors, such as Ritlecitinib, include an increased risk of infections, including serious infections, and potential development of malignancies. Laboratory abnormalities, such as changes in blood counts and liver enzymes, have also been reported. Other side effects may include gastrointestinal issues, headaches, and elevated cholesterol levels. It is important to monitor patients regularly to manage these risks effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Celiac Disease that are similar to Ritlecitinib, a Janus kinase (JAK) inhibitor. The primary management for Celiac Disease remains a strict gluten-free diet. Clinical trials, such as the one involving Ritlecitinib, are ongoing to explore new therapeutic options.

What other types of research exist?

Promising, novel alternatives to Ritlecitinib for Celiac Disease patients in 2024 may include other Janus kinase (JAK) inhibitors or treatments targeting interleukin pathways, such as anti-IL-23 agents. These treatments have shown efficacy and safety in other autoimmune conditions and may be under investigation for Celiac Disease.

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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)

Must not have

A diagnosis of any other inflammatory gastrointestinal disorder

A history of any abdominal or pelvic surgery <3 months before trial enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 1 year.

Summary

This trial is testing Ritlecitinib to see if it can help adults with celiac disease in remission avoid symptoms when they eat gluten. Participants will take either the drug or a non-active substance and eat a small amount of gluten regularly. The drug aims to block immune signals that cause inflammation.

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.

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.

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 below

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I have celiac disease, follow a strict gluten-free diet for 6+ months, and my tests show improvement.

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My BMI is between 17 and 40, and I weigh more than 45 kg.

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I have celiac disease, follow a strict gluten-free diet for 6+ months, and my tests show improvement.

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I agree to prevent pregnancy during the trial.

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I am positive for HLA-DQ2.5 or HLA-DQ8.

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I am between 18 and 75 years old.

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I am positive for HLA-DQ2.5 or HLA-DQ8.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with an inflammatory bowel condition.

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I have not had any abdominal or pelvic surgery in the last 3 months.

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I need surgery soon or have it scheduled during the study period.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Small Intestinal Histology based on Vh:Cd ratio

Patient Reported Outcome Surveys (CeD PRO survey evaluation)

Secondary study objectives

Changes in Small Intestinal Histology of intraepithelial lymphocytes (IELs)

Serology

Other study objectives

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 more

Trial 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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Celiac Disease is a strict gluten-free diet, which eliminates the ingestion of gluten, thereby preventing the autoimmune response that damages the small intestine. Emerging treatments, such as Janus kinase (JAK) inhibitors like Ritlecitinib, work by blocking specific pathways involved in the inflammatory response. JAK inhibitors can potentially reduce the immune-mediated damage to the intestinal lining, offering an alternative for patients who do not fully respond to a gluten-free diet. This is significant for Celiac Disease patients as it provides a potential therapeutic option to manage symptoms and intestinal damage more effectively.

Treatment failure in coeliac disease: a practical guide to investigation and treatment of non-responsive and refractory coeliac disease.