Recruiting

DONQ52 for Symptomatic Celiac Disease on Gluten-free Diet

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Study Aim

This study aims to evaluate the effectiveness of DONQ52 in improving intestinal health in people with symptomatic celiac disease who are on a gluten-free diet.

What is being tested

Placebo DONQ52

+ Simulated Inadvertent Gluten Exposure (SIGE) capsule

+ DONQ52

DrugDietary Supplement
Who is being recruted

Celiac Disease+4

+ Digestive System Diseases

+ Gastrointestinal Diseases

From 18 to 75 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorChugai Pharmaceutical
Study ContactClinical trials information
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 16, 2025

Actual date on which the first participant was enrolled.

This study is focused on finding out how effective a new drug called DONQ52 is for people with celiac disease, particularly those who still have intestinal damage and symptoms even though they are trying to follow a strict gluten-free diet. The aim is to see if this drug can help repair damage in the small intestine and reduce the symptoms caused by gluten exposure. This is important because many people with celiac disease continue to experience health issues despite avoiding gluten, and this study could lead to better treatments and improved quality of life for them. Participants in the study will receive either the drug DONQ52 or a placebo, which is a substance with no active medication, to compare the effects. The treatment is administered to see if it can improve the structure of the small intestine, specifically measuring changes in a ratio that indicates the health of the intestinal lining. The study will assess whether the drug helps in restoring the normal structure of the intestine and reducing symptoms. Researchers will use a method to analyze changes in this ratio over time, with a focus on whether the drug leads to improvements compared to the placebo.

Official TitleA Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (DAISY STUDY)
Principal SponsorChugai Pharmaceutical
Study ContactClinical trials information
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Celiac DiseaseDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic Diseases

Criteria

8 inclusion criteria required to participate
Attempting a GFD for at least 12 months prior to the screening visit. - The participants should be instructed not to alter dietary habits including a GFD during the study period.

Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.

Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1\*05 and HLA-DQB1\*02) (homozygous or heterozygous).

Body mass index (BMI) of 18 to 40 (kg/m2) at screening.

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11 exclusion criteria prevent from participating
Helicobacter pylori tests that indicate current infection.

Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.

Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.

History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Recruiting

Chandler Clinical Trials

Chandler, United StatesOpen Chandler Clinical Trials in Google Maps
Recruiting

Scottsdale Clinical Trials

Scottsdale, United States
Recruiting

Associates in Gastroenterology, PC

Colorado Springs, United States
Recruiting

Stamford Therapeutics Consortium

Stamford, United States
Recruiting
11 Study Centers