DRI17963
Research type
Research Study
Full title
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 non-responsive celiac disease as an adjunct to a gluten-free diet
IRAS ID
1009840
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2024-511213-38
Clinicaltrials.gov Identifier
Research summary
Celiac disease (CeD) is a chronic disease that is characterized by damage to the small intestine, is triggered by the consumption of gluten, and usually causes diarrhea, weight loss, malnutrition, as well as other symptoms. This disease can affect the health, social functioning, and quality of life for patients. Currently, there is no therapy that can reliably prevent the effects of gluten or treat CeD. The only treatment for CeD is a gluten free diet, but up to 30% of patients still have symptoms on a gluten free diet. There is a need for new treatments along with the use of a strict gluten free diet for patients with CeD. In this study, researchers want to check how safe and effective amlitelimab is in treating the symptoms of CeD when injected under the skin. Amlitelimab has been well tolerated in clinical studies and is expected to improve the condition of CeD. This study is a double-blind, placebo-controlled, 6-arm study where each participant is treated for 24 weeks. The study evaluates how effective and safe amlitelimab is in adult participants with Non-Responsive Celiac Disease as an adjunct to a gluten free diet, compared to a placebo. “Double-blind” means that neither the participant taking part, nor the study doctors know who is given the medicine or the placebo. This is done to make sure that the study results are not influenced in any way. In this study, placebo is used to better see the effect of the active medicine being compared to having no active medicine.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0409
Date of REC Opinion
23 Jul 2024
REC opinion
Further Information Favourable Opinion