Regeneron Pharmaceuticals ((REGN)), Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals and Sanofi are conducting a Phase 3 clinical study titled A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps. The study aims to assess the efficacy, safety, and tolerability of the drug Itepekimab in treating chronic rhinosinusitis with nasal polyps, a condition that significantly affects quality of life.
The intervention involves testing two dosing regimens of Itepekimab, an anti-IL-33 monoclonal antibody, administered subcutaneously, alongside a nasal spray, to determine its effectiveness as an add-on therapy.
This study is designed as a randomized, parallel-group trial with quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocations. The primary purpose is to evaluate treatment efficacy over a 52-week period.
The study began on February 6, 2025, with an estimated completion timeline of 76 weeks per participant, including a treatment and follow-up period. The latest update was submitted on July 14, 2025, indicating ongoing recruitment.
The outcome of this study could significantly impact the market, potentially boosting the stock performance of Regeneron and Sanofi if results are favorable. It may also influence investor sentiment positively, given the demand for effective treatments in this therapeutic area. Competitors in the pharmaceutical industry will be closely monitoring these developments.
The study is currently ongoing, with further details available on the ClinicalTrials portal.