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. Investigational treatments, such as DONQ52, aim to manage or treat Celiac Disease by targeting specific pathways involved in the immune response to gluten. These treatments may work by inhibiting the activity of tissue transglutaminase (tTG) or modulating the immune system to reduce inflammation and intestinal damage. These mechanisms are crucial for Celiac Disease patients as they offer potential alternatives to a gluten-free diet, which can be challenging to maintain and may not fully alleviate symptoms in all patients.

What side effects are associated with this type of intervention?

Common treatments for celiac disease primarily involve a strict gluten-free diet, which generally has no direct side effects but can be challenging to maintain and may lead to nutritional deficiencies if not well-managed. For refractory celiac disease, treatments may include immunosuppressive drugs like corticosteroids, which can cause side effects such as weight gain, osteoporosis, and increased infection risk. Investigational drugs like DONQ52, aimed at managing celiac disease, are being studied for safety and tolerability, and potential side effects could include gastrointestinal symptoms, headache, and hypersensitivity reactions, similar to other experimental treatments in this category.

What prior FDA approvals exist?

Currently, there are no FDA-approved drugs specifically for the treatment of celiac disease. The primary management strategy for celiac disease is a strict gluten-free diet. Investigational drugs like DONQ52 are being studied to assess their safety, tolerability, and potential benefits in well-controlled celiac disease patients. These investigational treatments aim to provide additional therapeutic options beyond dietary management.

What other types of research exist?

Promising novel alternatives to DONQ52 for celiac disease patients include larazotide acetate, a tight junction regulator that has shown efficacy in reducing symptoms by preventing gluten from crossing the intestinal barrier, and latiglutenase, an enzyme therapy designed to break down gluten in the stomach before it can trigger an immune response. Both therapies are in advanced stages of clinical trials and have demonstrated potential in improving symptoms and quality of life for celiac disease patients.

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Unknown

DONQ52 for Celiac Disease

Verified Trial

Phase 1

Recruiting

Research Sponsored by Chugai Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You have been diagnosed with Celiac Disease

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 246 days

Summary

This trial is testing a new drug called DONQ52 in patients with well-managed celiac disease. The study has two parts: one where patients receive single doses and another where they receive multiple doses. The goal is to see if the drug is safe and well-tolerated.

Who is the study for?

This trial is for people with celiac disease who have mild symptoms or are well-controlled, carry the HLA-DQ2.5 gene, and have been on a gluten-free diet for at least one year. Participants must also have a medical diagnosis confirmed by biopsies and positive serology tests. Those with refractory celiac disease or positive serology markers (tissue transglutaminase-2, deamidated gliadin peptide-IgA/G) cannot join.

What is being tested?

The study is testing DONQ52's safety and how it's processed in the body in two parts: Part A gives patients one dose to see how they react, while Part B gives them multiple doses over time. The effects of DONQ52 will be compared to a placebo (a treatment without any active drug).

What are the potential side effects?

Since this is an investigational drug, specific side effects of DONQ52 are not yet fully known but may include typical drug reactions such as digestive discomfort, headaches, allergic reactions or other unforeseen issues related to medication intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 246 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 246 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 246 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)

Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)

+1 more

Secondary study objectives

Immunogenicity

Pharmacokinetics; Area under the serum concentration time curve [AUC]

Pharmacokinetics; Half life [T1/2]

+3 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: SAD Cohort 4Experimental Treatment2 Interventions

All randomized patients will receive one dose of either DONQ52 Dose D or placebo

Group II: SAD Cohort 3Experimental Treatment2 Interventions

All randomized patients will receive one dose of either DONQ52 Dose C or placebo

Group III: SAD Cohort 2Experimental Treatment2 Interventions

All randomized patients will receive one dose of either DONQ52 Dose B or placebo

Group IV: SAD Cohort 1Experimental Treatment2 Interventions

All randomized patients will receive one dose of either DONQ52 Dose A or placebo

Group V: MAD Cohort 3Experimental Treatment2 Interventions

All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo

Group VI: MAD Cohort 2Experimental Treatment2 Interventions

All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo

Group VII: MAD Cohort 1Experimental Treatment2 Interventions

All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility 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. Investigational treatments, such as DONQ52, aim to manage or treat Celiac Disease by targeting specific pathways involved in the immune response to gluten. These treatments may work by inhibiting the activity of tissue transglutaminase (tTG) or modulating the immune system to reduce inflammation and intestinal damage. These mechanisms are crucial for Celiac Disease patients as they offer potential alternatives to a gluten-free diet, which can be challenging to maintain and may not fully alleviate symptoms in all patients.

Outcome measures in coeliac disease trials: the Tampere recommendations.Current status of drugs in development for celiac disease.Treatment failure in coeliac disease: a practical guide to investigation and treatment of non-responsive and refractory coeliac disease.