Non Responsive Coeliac Disease – Aspirion Study
A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Coeliac Disease as an Adjunct to a Gluten-free Diet.
Study Aim
The purpose of this study is to evaluate the effectiveness of the investigational medication in improving intestinal health by comparing it to a placebo.
Eligibility
Adults aged 18 to 75 years with a diagnosis of coeliac disease and a history of biopsy-proven coeliac disease can participate. They must have been on a gluten-free diet for at least 12 months and willing to maintain it during the study. Participants need to have moderate or greater gastrointestinal symptoms related to gluten exposure.
What Is Involved
The study will last for up to 48 weeks. The study requires 10 visits.
The investigational medication is administered as a subcutaneous injection.
