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Trial intelligence / Profile preview
Dupilumab in children aged 2 to under 6 years with uncontrolled asthma or recurrent severe wheeze
2023-504331-41-00Phase 3Authorised
- Sponsor
- Sanofi
- Start
- Aug 2024
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 16
01
Overview
Phase 3, randomised, double-blind trial in asthma comparing Dupilumab add-on therapy with Placebo add-on therapy (2 arms). Primary endpoints: Annualized rate of severe asthma exacerbations and Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent discontinuation. Planned start Aug 2024; status: authorised.
02
Drugs
03
Conditions
asthma
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Study design, results and competitive context are available in the Gosset platform where reported.
Competitive context
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