Trial intelligence / Profile preview

Dupilumab in Children 2 to <6 Years With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze

NCT06191315Phase 3Enrolling by invitation

Sponsor
Sanofi
Start
Jan 2024
Primary completion
Dec 2028
Modality
Monoclonal Antibodies
Countries
16
01

Overview

Phase 3, randomised, double-blind trial in asthma comparing Dupilumab with Placebo (2 arms). Primary endpoints: Annualized rate of severe asthma exacerbations at 52 weeks and Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation at 116 weeks. Started Jan 2024; status: enrolling by invitation.

02

Drugs

03

Conditions

asthma

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