Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05394116 | A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP) | PHASE3 | ACTIVE NOT_RECRUITING | 63 | — | — | Nov 21, 2022 | Feb 27, 2029 | Jan 16, 2026 | 22 | United States, Australia +16 |
| Arm | Type | Description |
|---|---|---|
| High dose Garetosmab | EXPERIMENTAL | Garetosmab is administered by intravenous (IV) administration every 4 weeks (Q4W) |
| Low dose Garetosmab | EXPERIMENTAL | Garetosmab is administered by IV administration Q4W |
| Placebo | EXPERIMENTAL | Placebo to match garetosmab, is supplied as a liquid solution without the monoclonal antibody (or the protein) and is administered IV Q4W. |
| Name | Type | Description |
|---|---|---|
| Garetosmab | DRUG | Garetosmab is supplied as a liquid drug product and will be administered IV. |
| Placebo | DRUG | Placebo to match garetosmab, is supplied as a liquid solution without the monoclonal antibody (or the protein) and is administered IV. |
Key Inclusion Criteria: 1. Clinical diagnosis of Fibrodysplasia Ossificans Progressiva (FOP) \[(based on findings of congenital malformation of the great toes, episodic soft tissue swelling, and/or progressive Heterotopic Ossification (HO)\] 2. Confirmation of FOP diagnosis with documentation of Ty...