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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05768854 | Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta | PHASE3 | ACTIVE NOT_RECRUITING | 69 | — | — | Jun 14, 2023 | Apr 1, 2027 | Feb 25, 2026 | 20 | United States, Brazil +5 |
| Arm | Type | Description |
|---|---|---|
| Intravenous Bisphosphonates (IV-BP) -> Setrusumab | ACTIVE_COMPARATOR | Participants on IV-BP will continue their existing dose/regimen per investigator discretion; for participants not on IV-BP, the dose/regimen will be determined by the investigator. After the active-controlled period, participants will receive Setrusumab during the extension period |
| Setrusumab | EXPERIMENTAL | Participants will receive Setrusumab during the active-controlled and extension period |
| Name | Type | Description |
|---|---|---|
| Bisphosphonate | DRUG | Administered per investigator discretion via intravenous (IV) infusion |
| Setrusumab | BIOLOGICAL | A fully human sclerostin neutralizing monoclonal antibody (mAb) administered once a month (QM) via intravenous (IV) infusion |
Inclusion Criteria: * Male or female 2 to \< 7 years of age at time of informed consent * Clinical diagnosis of OI Types I, III, or IV confirmed by identification of genetic mutation in COL1A1 or COL1A2 * History of ≥ 1 fracture in the past 12 months, ≥ 2 fractures in the past 24 months, or ≥ 1 fem...