DONQ52 for Celiac Disease

No longer recruiting at 22 trial locations

Overseen By Clinical trials information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Chugai Pharmaceutical

Disqualifiers: Refractory celiac, Positive serology

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called DONQ52 to determine its safety and tolerability in people with celiac disease. The trial consists of two parts: one where participants receive a single dose and another with multiple doses. Each group receives either a different dose of the drug or a placebo (a pill with no active drug). Individuals diagnosed with celiac disease who adhere to a gluten-free diet and experience mild or no symptoms might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DONQ52 could be a safe treatment for people with celiac disease. Studies have found that DONQ52 stops the immune system from reacting to gluten without affecting other parts of the immune system, suggesting it might be easy for the body to handle. As this trial is in an early stage, it primarily focuses on assessing the treatment's safety and tolerability. While initial evidence is promising, more information is needed to confirm its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for celiac disease?

Researchers are excited about DONQ52 for celiac disease because it offers a potentially new approach to managing the condition. Unlike current treatments, which primarily involve strict adherence to a gluten-free diet, DONQ52 might directly target the immune response that causes the symptoms of celiac disease. This new mechanism could provide relief for patients who struggle to maintain a gluten-free lifestyle or who experience symptoms despite dietary restrictions. Additionally, the trial explores different dosing regimens, which could lead to a more personalized treatment approach.

What evidence suggests that DONQ52 might be an effective treatment for celiac disease?

Research shows that DONQ52 targets a specific part of the immune system related to celiac disease. It blocks the body's reaction to gluten in people with this condition. Studies have found that DONQ52 can reduce immune reactions to gluten without affecting the rest of the immune system. Specifically, it stops certain immune cells from reacting to gluten. This suggests that DONQ52 could help manage celiac disease symptoms by reducing harmful immune responses to gluten. Participants in this trial will receive different doses of DONQ52 or a placebo to evaluate its effectiveness and safety. ^{1 2 4 6 7}

Who Is on the Research Team?

Sponsor Chugai Pharmaceutical Co. Ltd

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with Celiac Disease

I only have mild symptoms of celiac disease.

I have the HLA-DQ2.5 gene.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive a single dose of either DONQ52 or placebo in ascending dose cohorts

4-8 weeks

Multiple Ascending Dose (MAD) Treatment

Participants receive multiple doses of either DONQ52 or placebo in ascending dose cohorts

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 246 days

What Are the Treatments Tested in This Trial?

Interventions

• DONQ52
• Placebo

Trial Overview

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).

How Is the Trial Designed?

Group I: SAD Cohort 4 Experimental Treatment 2 Interventions

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

Group II: SAD Cohort 3 Experimental Treatment 2 Interventions

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

Group III: SAD Cohort 2 Experimental Treatment 2 Interventions

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

Group IV: SAD Cohort 1 Experimental Treatment 2 Interventions

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

Group V: MAD Cohort 3 Experimental Treatment 2 Interventions

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

Group VI: MAD Cohort 2 Experimental Treatment 2 Interventions

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

Group VII: MAD Cohort 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Chugai Pharmaceutical

Lead Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University

Citations

1.

celiac.org

celiac.org/2024/06/07/a-promising-new-approach-from-chugai-pharmaceuticals-for-blocking-gluten-induced-immune-response-in-celiac-disease/

A Promising New Approach from Chugai Pharmaceuticals ...

This proof-of-concept study demonstrates that targeting HLA-DQ2.5 with a specific antibody like DONQ52 can effectively block the immune response triggered by ...

2.

celiac.org

celiac.org/2024/01/18/whats-new-in-celiac-disease-news-chugai-pharmaceutical-publishes-non-clinical-research-results-on-donq52-for-celiac-disease/

What's New in Celiac Disease News? Chugai ...

The findings show the potential for DONQ52 to block the immune response to gluten in celiac disease without affecting the rest of the immune system.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1521661624003681

A bispecific antibody targeting HLA-DQ2.5-gluten peptides ...

DONQ52 can significantly block HLA-DQ2.5-restricted T cell responses to the most highly immunogenic gluten peptides in CeD.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38768856/

A bispecific antibody targeting HLA-DQ2.5-gluten peptides ...

Results: In HLA-DQ2.5+ CeD patients, DONQ52 reduced T cell responses to all wheat gluten peptides to an equivalent or more effective degree than pan-HLA-DQ ...

5.

nature.com

nature.com/articles/s41467-023-44083-4

Characterizations of a neutralizing antibody broadly ...

To estimate clinical efficacy of DONQ52 against HLA-DQ2.5+ CeD patients with individually distinctive pathogenic gluten epitopes, we addressed ...

6.

anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624000316505

ANZCTR - Registration

Public title. Study of the safety, pharmacokinetics, immunogenicity, and biological effects of DONQ52 in celiac disease patients with gluten challenge. Query ...

7.

mayo.edu

mayo.edu/research/clinical-trials/cls-20542635

Study of the Safety, Tolerability, Pharmacokinetics and ...

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of DONQ52 in celiac disease patients.