DONQ52 for Celiac Disease

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Chugai Pharmaceutical

Disqualifiers: Refractory celiac, Cancer, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 27 weeks

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DONQ52, an experimental therapy for people with celiac disease. This condition occurs when gluten consumption damages the small intestine, causing symptoms like stomach pain and tiredness. The trial aims to determine if DONQ52 can heal the intestine and reduce symptoms when gluten exposure occurs, despite a strict gluten-free diet. Participants will receive either the treatment or a placebo (a substance with no active ingredients) along with a special gluten pill to assess the effects. Ideal candidates have maintained a gluten-free diet for at least a year and recently experienced at least two gluten-related symptom events. As a Phase 2 trial, this research measures how well DONQ52 works in an initial, smaller group, allowing participants to contribute to important findings.

Is there any evidence suggesting that DONQ52 is likely to be safe for humans?

Research has shown that DONQ52, a treatment being tested for celiac disease, has promising safety results from earlier studies. These studies found that most patients tolerated the treatment well. The research examined the safety and comfort of the treatment at various doses. Although more information is still being gathered, results so far suggest that DONQ52 is safe, with no major side effects reported. This indicates that the treatment might be safe for people with celiac disease, but ongoing trials will provide more detailed information. ^{1 2 3 4 5}

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

Most treatments for celiac disease focus on strict gluten avoidance, which can be challenging and limiting. DONQ52 is unique because it combines a subcutaneous injection with a SIGE Gluten capsule, potentially offering a more proactive approach. This treatment is particularly exciting because it targets the immune response to gluten, which could provide relief to patients who struggle with diet alone. Researchers are hopeful that this innovative method could improve quality of life for those with celiac disease.

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

Research has shown that DONQ52 holds promise for treating celiac disease. Studies have found that DONQ52 effectively stops the immune reaction caused by gluten, the main issue in celiac disease. In people with celiac disease, DONQ52 reduced the activity of T cells (a type of immune cell) against gluten. This was as effective or even better than other treatments targeting similar immune responses. By doing so, DONQ52 helps reduce damage to the small intestine and could ease symptoms for those who struggle to maintain a gluten-free diet. These findings suggest a potential benefit for individuals with celiac disease. Participants in this trial will receive either DONQ52 or a placebo, both combined with a SIGE Gluten capsule, to further evaluate its effectiveness. ^{2 3 4 6 7}

Who Is on the Research Team?

Chugai Pharmaceutical Co., Ltd.

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for individuals with celiac disease who are trying to stick to a gluten-free diet but still have intestinal damage and symptoms like diarrhea, abdominal pain, or tiredness. They must have a BMI of 18-40, experienced at least two symptom events in the past month, and be willing to ingest gluten-free products and undergo endoscopies.

Inclusion Criteria

I am willing to have 2 endoscopies with biopsies during the study.

My BMI is between 18 and 40.

My blood test shows 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

Treatment

Participants receive DONQ52 or placebo with SIGE Gluten capsule from baseline to Week 27

27 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DONQ52

Trial Overview

The study tests DONQ52's effectiveness against small intestine damage from gluten exposure in people with celiac disease. Participants will either receive DONQ52 or a placebo while maintaining their gluten-free diets and being exposed to simulated inadvertent gluten (SIGE).

How Is the Trial Designed?

Group I: DONQ52 + SIGE Gluten capsule Experimental Treatment 2 Interventions

DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

Group II: Placebo + SIGE Gluten capsule Placebo Group 2 Interventions

Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07239336

Phase II Study of DONQ52 in Active Celiac Disease

The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, ...

2.

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 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1521661624003681

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

5+ CeD patients, DONQ52 reduced T cell responses to all wheat gluten peptides to an equivalent or more effective degree than pan-HLA-DQ antibody blockade. It ...

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.

beyondceliac.org

beyondceliac.org/research-news/celiac-disease-drugs-show-progress/

Celiac disease drugs show progress | BeyondCeliac.org

DONQ52, a drug being developed by Chugai Pharmaceuticals to treat celiac disease by blocking the immune responses that occur, was effective in blocking gluten- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05425446

NCT05425446 | Study of the Safety, Tolerability, ...

This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a ...

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.