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)

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

Age range

18–75 years

Sex

All

Healthy volunteers

No

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

Locations (38)