drugset / Trial / NCT04577820

Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)

NCT04577820

Phase 3 Withdrawn Regeneron Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The primary safety objective of the study is to assess the safety and tolerability of garetosmab in Japanese male and female adult patients with FOP. The primary efficacy objective of the study is to assess the effect of garetosmab on Heterotopic ossification (HO) in Japanese adult patients with FOP, as determined by the number of new heterotopic bone lesions identified by computed tomography (CT).

Timeline

Start
2021-10-13
Primary completion
2022-03-01
Completion
2022-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Garetosmab Monoclonal antibody Intravenous