Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi is conducting a Phase 2a/b study titled 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 Celiac Disease as an Adjunct to a Gluten-free Diet. The study aims to evaluate the efficacy and safety of amlitelimab in adults with non-responsive celiac disease (NRCD) who are on a gluten-free diet. The primary goal is to assess amlitelimab’s effect on gluten-induced changes in the intestinal mucosa.
The intervention being tested is amlitelimab, a subcutaneous injection, intended to treat NRCD. It is compared against a placebo, with both groups also receiving dietary supplements like gluten-free products or simulated inadvertent gluten exposure (SIGE).
The study is designed as a randomized, double-blind, placebo-controlled, parallel-group trial. It employs a quadruple masking method, meaning the participant, care provider, investigator, and outcomes assessor are unaware of the treatment allocations. The primary purpose is treatment-focused.
The study began on August 14, 2024, with its last update on August 14, 2025. The primary completion and estimated completion dates have not been specified, indicating the study is ongoing.
This clinical update could positively impact Sanofi’s stock performance and investor sentiment, as successful results could lead to a new treatment option for NRCD. In the competitive landscape, advancements in celiac disease treatments are keenly watched by investors.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.