Phase 2 Study of DONQ52 Treatment in Adults With Active Celiac Disease and Persistent Symptoms Despite a Gluten-Free Diet

What this Trial Is About

Researchers are evaluating the effects of DONQ52 on small intestinal damage and celiac-related symptoms caused by gluten exposure in people with celiac disease who are trying to maintain a gluten-free diet. This Phase II study aims to compare the investigational drug DONQ52 to a placebo in participants with ongoing duodenal damage and persistent symptoms despite adhering to a gluten-free diet. The study focuses on patients with active celiac disease confirmed by specific genetic markers and clinical history. Participants are randomly assigned to receive either DONQ52 or a placebo, both given as subcutaneous injections according to protocol, along with oral Simulated Inadvertent Gluten Exposure SIGE capsules to mimic accidental gluten intake. The study period includes treatment and observation phases, with participants maintaining their gluten-free diet throughout. The treatment is administered over several weeks, and participants undergo two upper gastrointestinal endoscopies with duodenal biopsies to assess intestinal damage. During the study, participants will have regular evaluations including symptom diaries focusing on gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, and bloating. Laboratory tests will monitor drug levels, immune response, and safety. The main outcome measured is the change in the villous height to crypt depth ratio in the intestines over 27 weeks. Safety and side effects will be tracked up to 47 weeks. Participants will also be monitored for antibodies against DONQ52 and overall symptom changes over the course of the study.

Study of DONQ52 in Active Celiac Disease