Trial intelligence / Profile preview

OPTIMA phase 3 study of garetosmab in fibrodysplasia ossificans progressiva

2023-508350-26-00Phase 3Completed

Sponsor
Regeneron Pharmaceuticals
Start
Mar 2023
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
18
01

Overview

Phase 3, randomised, double-blind trial in fibrodysplasia ossificans progressiva (FOP) comparing Garetosmab with Placebo matching to garetosmab (2 arms). Primary endpoints: Number of new heterotopic ossification lesions and Incidence and severity of treatment-emergent adverse events of special interest. Started Mar 2023; status: completed.

02

Drugs

garetosmab
03

Conditions

fibrodysplasia ossificans progressiva (FOP)

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