Trials / Recruiting
RecruitingNCT07239336
Study of DONQ52 in Active Celiac Disease
A 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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo DONQ52 | Placebo DONQ52 subcutaneous injection |
| DIETARY_SUPPLEMENT | Simulated Inadvertent Gluten Exposure (SIGE) capsule | SIGE gluten capsules orally |
| DRUG | DONQ52 | DONQ52 subcutaneous injection |
| DIETARY_SUPPLEMENT | Simulated Inadvertent Gluten Exposure (SIGE) capsule | SIGE gluten capsules orally |
Timeline
- Start date
- 2025-12-16
- Primary completion
- 2027-06-15
- Completion
- 2027-12-15
- First posted
- 2025-11-20
- Last updated
- 2026-04-09
Locations
29 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07239336. Inclusion in this directory is not an endorsement.