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

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

Outcome

Outcome not reported

Stopped: “Phase 2 Study R2477-FOP-1940 has been withdrawn and the next phase of the development program is being planned”

Drugs

Indications