Phase 2 trial now enrolling in the US
Ashley Berg, Associate Director of Science
The CEC-013 Study, a new phase 2 clinical trial, is now enrolling in the United States. This study is testing a potential celiac disease treatment, ZED1227, being developed in collaboration between Dr. Falk Pharma and Takeda Pharmaceuticals. Phase 2 clinical trials study the efficacy and safety of a drug that has already completed phase 1 clinical trials.
When people with celiac disease ingest gluten, the immune system reacts as if the gluten is a foreign invader. ZED1227 is designed to block transglutaminase 2 (tTG), an enzyme that reacts with fragments of gluten. This reaction makes the fragments more recognizable to the cells that cause inflammation and destruction of the small intestinal villi in those who have celiac disease. ZED1227 is intended to prevent the immune response that drives celiac disease by blocking tTG.
A previous Phase 2a trial showed ZED1227 has a protective effect on the lining of the intestine and against symptoms during a six-week gluten challenge. This CEC-013 Study will test different ZED1227 doses. Additional analysis showed a reduction in inflammatory markers related to gluten exposure.
The CEC-013 Study is enrolling 356 people with celiac disease in the United States and Europe. To qualify, participants must be 18-80 years old, have a diagnosis of celiac disease, and still be experiencing symptoms despite following the gluten-free diet for at least 1 year. Other criteria will also apply. There will be approximately 20 sites in the US.
After a screening period to determine qualifications, trial participants will be randomly assigned to take different doses of ZED1227 or placebo for 15 weeks. During this treatment period, participants will eat a granola bar several times per week with a meal. The granola bars contain a small amount of gluten, about the same as someone might consume through cross contact at a restaurant. It is important for all study participants to consume this gluten through the study so investigators will know if the drug works with gluten exposure. After the 15 week treatment period, there is a 4 week non-treatment period where participants are not taking ZED1227 or eating granola bars.
Participants will also undergo two upper endoscopies with biopsy to monitor changes in the intestines before and after study treatment and gluten exposure. Blood and urine samples will be collected throughout the study. Participants will maintain a daily symptom diary, and complete questionnaires throughout the duration of the study.
Beyond Celiac is working with Dr. Falk Pharma and Takeda Pharmaceuticals to help raise awareness for this trial as part of our commitment to accelerating research. For more information about the CEC-013 study and to see if you qualify, visit this link. More information about the trial is also available at ClinicalTrials.gov.