Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi has initiated a Phase 2a/b clinical 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 subcutaneous amlitelimab in adults with nonresponsive celiac disease (NRCD) who are on a gluten-free diet. The primary goal is to assess the drug’s impact on gluten-induced changes in the intestinal mucosa.
The intervention being tested is amlitelimab, administered subcutaneously. This drug is intended to address NRCD by improving intestinal health and reducing symptoms associated with gluten exposure.
The study follows a randomized, parallel-group design with a quadruple masking approach, involving participants, care providers, investigators, and outcomes assessors. The primary purpose is treatment-focused, aiming to provide a new therapeutic option for NRCD patients.
The study commenced on August 29, 2024, with an estimated primary completion date in 2025. The last update was submitted on July 7, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
This study could significantly impact Sanofi’s stock performance, as successful results may enhance investor confidence and position Sanofi as a leader in the NRCD treatment market. Competitors in the pharmaceutical industry will likely monitor these developments closely.
The study is ongoing, with further details available on the ClinicalTrials portal.