Study of DONQ52 in Active Celiac Disease

Conditions

• Celiac Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo DONQ52 — DRUG
  Placebo DONQ52 subcutaneous injection
• Simulated Inadvertent Gluten Exposure (SIGE) capsule — DIETARY_SUPPLEMENT
  SIGE gluten capsules orally
• DONQ52 — DRUG
  DONQ52 subcutaneous injection
• Simulated Inadvertent Gluten Exposure (SIGE) capsule — DIETARY_SUPPLEMENT
  SIGE gluten capsules orally

Study Details

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.

Key Dates

Start date

Dec 16, 2025

Status verified

May 2026

Primary completion

Jun 15, 2027

Completion

Dec 15, 2027

Study Design

Enrollment

92 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo + SIGE Gluten capsule
  Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally
• Experimental: DONQ52 + SIGE Gluten capsule
  DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally

Primary Outcome Measure

Change in Villous Height to Crypt Depth Ratio (Vh:Cd) [ Time Frame: Baseline to Week 27 ]

Central Contacts

• Clinical trials information
  only use Email
  [email protected]

Locations (49)

Find similar trials in Anniston, AL

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