Trial intelligence / Profile preview

Dupixent for indolent systemic mastocytosis with skin involvement

2023-509111-89-00Phase 3Authorised

Sponsor
Medical University of Gdańsk
Start
Mar 2025
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
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Overview

Phase 3, randomised, double-blind trial in indolent systemic mastocytosis (ISM) comparing Dupixent + fexofenadine with Placebo + fexofenadine (2 arms). Primary endpoints: Reduction in incidence of mast cell mediator–related symptoms (anaphylaxis and flushing), Reduction in extent of skin lesions and 4 more. Planned start Mar 2025; status: authorised.

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Drugs

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Conditions

indolent systemic mastocytosis (ISM)

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