A new phase 2 study is recruiting patients at a limited number of sites in the United States.
Ashley Berg, Associate Director of Science
Chugai Pharmaceuticals is testing their potential celiac disease treatment, DONQ52, in a phase 2 clinical trial called the DAISY Study. Phase 2 clinical trials study the efficacy and safety of a drug that has already completed Phase 1 clinical trials. In previous studies, DONQ52 was shown to successfully block the immune reaction to gluten in mice, while leaving the rest of the immune system intact. The LILY Phase 1 study showed an excellent safety profile and no serious adverse events were reported in this study. The Phase 2 DAISY study is designed to determine efficacy and small bowel healing while continuing to evaluate safety in a larger patient population.
When people with celiac disease ingest gluten, the immune system reacts as if the gluten is a foreign invader. DONQ52 is a monoclonal antibody that is designed to inhibit this reaction of the immune system to gluten, stopping the process that causes the damage of celiac disease. Modulating the immune response is a primary strategy within the current drug development pipeline to provide treatment options beyond the gluten-free diet.
Study Details
The DAISY study is enrolling 92 people with celiac disease in the US, New Zealand, and Australia, who continue to have symptoms despite following the gluten-free diet for at least one year. Once participants have successfully completed the initial screening, they will be randomly assigned to receive either DONQ52 injections or a placebo.
Participants will also be randomized to take a capsule three times a week for up to 6 months. This capsule will contain either a small amount of gluten or a gluten-free placebo. To reflect real-world conditions, the exposure amount simulates the accidental gluten intake that occurs via cross-contact, even for those actively maintaining a gluten-free diet. Participants will also have two upper endoscopies with biopsy to monitor changes in the intestines following study treatment and gluten exposure.
DAISY Study participants will remain in the study for approximately 1 year. To qualify, participants must be 18-75 years old, have a diagnosis of celiac disease with intestinal damage, and be still experiencing symptoms despite attempting the gluten-free diet for at least 1 year. Other qualifications will also apply.
Those who qualify and give written informed consent will receive study medication or placebo at no cost, care from local doctors, and reimbursement for travel expenses.
Beyond Celiac is working with Chugai Pharmaceuticals to help raise awareness for this trial as part of our commitment to accelerating research. For more information about the DAISY study and to see if you qualify, visit this link. More information about the trial is also available at ClinicalTrials.gov.