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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06636071 | Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta | PHASE3 | ACTIVE NOT_RECRUITING | 6 | — | — | Oct 25, 2024 | Jan 1, 2028 | Mar 13, 2026 | 3 | Japan |
| NCT05125809 | Setrusumab vs Placebo for Osteogenesis Imperfecta | PHASE2 | ACTIVE NOT_RECRUITING | 183 | — | — | Feb 21, 2022 | Apr 1, 2027 | Feb 25, 2026 | 44 | United States, Australia +9 |
| Arm | Type | Description |
|---|---|---|
| Setrusumab | EXPERIMENTAL | - |
| Low Dose Setrusumab -> Open-Label (OL) Setrusumab Selected Dose | EXPERIMENTAL | Single-blind setrusumab low dose during Phase 2 followed by open-label setrusumab selected dose During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician |
| High Dose Setrusumab -> OL Setrusumab Selected Dose | EXPERIMENTAL | Single-blind setrusumab high dose during Phase 2 followed by open-label setrusumab During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician |
| Setrusumab Selected Dose -> OL Setrusumab Selected Dose | EXPERIMENTAL | Double-blind setrusumab selected dose during Phase 3 followed by open-label setrusumab During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician |
| Placebo -> OL Setrusumab Selected Dose | PLACEBO_COMPARATOR | Double-blind placebo during Phase 3 followed by open-label setrusumab During treatment and treatment extension periods, participants may receive supplementation with calcium and vitamin D to maintain normal values as directed by the treating physician |
| Name | Type | Description |
|---|---|---|
| setrusumab | BIOLOGICAL | A fully human sclerostin neutralizing monoclonal antibody (mAb) administered once a month (QM) via intravenous (IV) infusion |
| Placebo | OTHER | A 5% dextrose/glucose solution administered QM via IV infusion |
Key Inclusion Criteria: * Clinical diagnosis of OI Type 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 femur, tibia, or humerus fracture in the past 24 months * Any prior ...