Trials / Withdrawn
WithdrawnNCT04577820
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Evaluation of Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | garetosmab | Repeated doses administered intravenously (IV) every four weeks (Q4W) |
Timeline
- Start date
- 2021-10-13
- Primary completion
- 2022-03-01
- Completion
- 2022-10-08
- First posted
- 2020-10-08
- Last updated
- 2021-11-01
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04577820. Inclusion in this directory is not an endorsement.