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Regeneron and Sanofi’s Phase 3 Study on Itepekimab: A Potential Game-Changer for Chronic Rhinosinusitis

Regeneron and Sanofi’s Phase 3 Study on Itepekimab: A Potential Game-Changer for Chronic Rhinosinusitis

Regeneron Pharmaceuticals ((REGN)), Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) 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 evaluate the effectiveness, safety, and tolerability of Itepekimab, an anti-IL-33 monoclonal antibody, in treating chronic rhinosinusitis with nasal polyps.

The intervention involves administering Itepekimab subcutaneously in high and low doses, alongside a nasal spray, to assess its impact compared to a placebo. The treatment is designed to improve symptoms in patients whose condition is not adequately controlled by current therapies.

This study is structured as a randomized, parallel-group trial with quadruple masking, meaning that participants, care providers, investigators, and outcome assessors are unaware of the treatment allocations. The primary goal is to determine the treatment’s effectiveness.

The study began on February 12, 2025, with an expected duration of up to 76 weeks per participant. The latest update was submitted on July 14, 2025, indicating the study is actively recruiting participants.

Market implications of this study could be significant for Regeneron and Sanofi, potentially boosting investor confidence if results show positive outcomes. This study places them in a competitive position within the pharmaceutical industry, particularly in the treatment of chronic rhinosinusitis with nasal polyps.

The study is ongoing, and further details can be accessed on the ClinicalTrials portal.

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