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 SA have initiated a Phase 3 clinical study titled ‘A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze.' The study aims to evaluate the efficacy and long-term safety of dupilumab in young children suffering from uncontrolled asthma and severe asthmatic wheeze, potentially offering a new treatment option for this vulnerable age group.
The study is testing the drug Dupilumab, administered via subcutaneous injection, against a placebo. Dupilumab is designed to reduce inflammation and improve asthma control in young children.
This interventional study employs a randomized, parallel assignment model with triple masking (participant, care provider, investigator) to ensure unbiased results. The primary purpose is treatment-focused, aiming to establish the drug’s safety and effectiveness.
The study began on January 3, 2024, with primary completion expected within 68 weeks for Part A, and an optional extension in Part B bringing the total duration to 120 weeks. The last update was submitted on July 1, 2025, indicating ongoing recruitment and study progress.
The study’s progress could influence Regeneron and Sanofi’s stock performance, as positive results may enhance investor confidence and market positioning in the pediatric asthma treatment sector. Competitors in the respiratory treatment market will be closely monitoring these developments.
The study is currently ongoing, with further details available on the ClinicalTrials portal.