DONQ52 for Symptomatic Celiac Disease on Gluten-free Diet
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.
Placebo DONQ52
+ Simulated Inadvertent Gluten Exposure (SIGE) capsule
+ DONQ52
Celiac Disease+4
+ Digestive System Diseases
+ Gastrointestinal Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.92 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy 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
Scottsdale Clinical Trials
Scottsdale, United StatesAssociates in Gastroenterology, PC
Colorado Springs, United StatesStamford Therapeutics Consortium
Stamford, United States