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Study of DONQ52 in Active Celiac Disease

NCT07239336 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-05-20

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2027-06-15
Completion
2027-12-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07239336 on ClinicalTrials.gov