Phase II Study of ZED1227 to Treat Symptoms in Adults With Celiac Disease Not Improved by a Gluten-Free Diet

What this Trial Is About

Researchers are evaluating the effects of ZED1227 in people with celiac disease who continue to experience symptoms despite following a gluten-free diet. This Phase II, double-blind, randomized, placebo-controlled trial aims to assess both the effectiveness and tolerability of the treatment. The study is sponsored by Dr. Falk Pharma GmbH and focuses on improving gastrointestinal symptoms related to celiac disease. Participants will receive oral treatment with varying daily doses of ZED1227 combined with SIGE or a placebo with SIGE. The trial includes several groups receiving low, medium, or high doses of ZED1227 or placebo, and the treatment period lasts at least 12 weeks. The design ensures participants and researchers do not know who receives the active drug or placebo to fairly compare results. During the study, participants will undergo symptom assessments using the CDSD GI Specific Symptom Score, evaluation of symptom-free days, and histological examinations of intestinal tissue. Blood tests will monitor serological markers related to celiac disease. Researchers will also track any changes in intestinal inflammation and safety. The trial will continue until August 2027, allowing careful monitoring of outcomes and side effects throughout the study period.

Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease