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

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

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 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 efficacy, safety, and tolerability of Itepekimab, an anti-IL-33 monoclonal antibody, in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.

The intervention involves subcutaneous administration of Itepekimab in both high and low doses, alongside a placebo group, with all participants receiving mometasone furoate nasal spray as an add-on therapy. The goal is to assess the drug’s effectiveness in managing CRSwNP symptoms.

This randomized, parallel-group study employs a quadruple masking approach to ensure unbiased results. The primary purpose is treatment, with participants undergoing a 52-week treatment period followed by a 20-week safety follow-up.

The study began on February 6, 2025, with primary completion expected in 2026. The last update was submitted on August 6, 2025, indicating ongoing recruitment.

For investors, this study could influence Regeneron and Sanofi’s stock performance, as successful results may enhance their competitive position in the pharmaceutical market. The focus on CRSwNP, a condition with limited treatment options, could attract significant market interest.

The study is currently ongoing, with further details available on the ClinicalTrials portal.

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