Study of DONQ52 in Active Celiac Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo DONQ52: Placebo DONQ52 subcutaneous injection
Simulated Inadvertent Gluten Exposure (SIGE) capsule: SIGE gluten capsules orally
DONQ52: DONQ52 subcutaneous injection
Simulated Inadvertent Gluten Exposure (SIGE) capsule: SIGE gluten capsules orally
Study summary
The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
Eligibility
Primary outcome measure(s)
- Change in Villous Height to Crypt Depth Ratio (Vh:Cd) — Baseline to Week 27
The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.
Trial sites (74)
| Facility | City | Region | Status |
|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | Recruiting |
| Birmingham Digestive Health Research | Homewood | Alabama | Recruiting |
| East View Medical Research | Mobile | Alabama | Recruiting |
| Chandler Clinical Trials | Chandler | Arizona | Recruiting |
| Research Solutions of Arizona, PC | Litchfield | Arizona | Recruiting |
| One of a Kind Clinical Research Center LLC | Scottsdale | Arizona | Recruiting |
| Scottsdale Clinical Trials | Scottsdale | Arizona | Recruiting |
| Gastroenterology and Liver Institute | Escondido | California | Recruiting |
| GMC Clinical Research, LLC | Folsom | California | Recruiting |
| Velocity Clinical Research, Gardena | Gardena | California | Recruiting |
| Om Research LLC | Lancaster | California | Recruiting |
| Clinical Applications Laboratories | San Diego | California | Recruiting |
| California Research Foundation | San Diego | California | Recruiting |
| Asthma and Allergy Associates, PC | Colorado Springs | Colorado | Recruiting |
| Associates in Gastroenterology, PC | Colorado Springs | Colorado | Recruiting |
| Mountain View Clinical Research, Inc. | Denver | Colorado | Recruiting |
| Stamford Therapeutics Consortium | Stamford | Connecticut | Recruiting |
| Novum Clinical Research | Clermont | Florida | Recruiting |
| Encore Borland Groover Clinical Research LLC | Jacksonville | Florida | Recruiting |
| Global Life Research Network | Miami | Florida | Recruiting |
| Wellness Clinical Research | Miami Lakes | Florida | Recruiting |
| Ocala GI Research | Ocala | Florida | Recruiting |
| Tropical Clinical Trials | Palmetto Bay | Florida | Recruiting |
| St. Johns Center for Clinical Research | Saint Augustine | Florida | Recruiting |
| Guardian Angel Research Center | Tampa | Florida | Recruiting |
| GI Alliance - Glenview | Glenview | Illinois | Recruiting |
| GI Alliance -Gurnee | Gurnee | Illinois | Recruiting |
| Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois | Recruiting |
| GI Alliance | Metairie | Louisiana | Recruiting |
| Velocity Clinical Research New Orleans | New Orleans | Louisiana | Recruiting |
| Portland Gastroenterology Center | Portland | Maine | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Mayo Clinic - Rochester | Rochester | Minnesota | Recruiting |
| GI Associates Research, LLC | Columbia | Missouri | Recruiting |
| Gateway GI Research, LLC | St Louis | Missouri | Recruiting |
| Oasis Clinical Research | Las Vegas | Nevada | Recruiting |
| Advanced Research Institute | Reno | Nevada | Recruiting |
| Akron Gastro Research, LLC | Akron | Ohio | Recruiting |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | Recruiting |
| Central Sooner Research | Norman | Oklahoma | Recruiting |
+ 34 more sites — see the full list on the official registry below.
More Chugai Pharmaceutical trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07239336 on ClinicalTrials.gov ↗ ← All trials in the USA