drugset / Trial / NCT04577820
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Garetosmab | Monoclonal antibody | — | Intravenous |