Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Setrusumab · 3 trials · 4 indications
Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA).
Assessed by finite element analysis (FEA) of models generated from HRpQCT images of the distal radius.
Assessed by FEA of models generated from HRpQCT images of the distal radius.
| 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 |
| Setrusumab 20 mg/kg (Blinded) | EXPERIMENTAL | Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. |
| Setrusumab 8 mg/kg (Blinded) | EXPERIMENTAL | Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. |
| Setrusumab 2 mg/kg (Blinded) | EXPERIMENTAL | Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. |
| Setrusumab 20 mg/kg (Open-Label) | EXPERIMENTAL | Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. |
| Placebo | PLACEBO_COMPARATOR | Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. |
| 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 |
| Calcium | DIETARY_SUPPLEMENT | tablets |
| Vitamin D | DIETARY_SUPPLEMENT | capsules |
| zoledronic acid (optional) | DRUG | Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician. |
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 ...
Setrusumab is an investigational monoclonal antibody being developed for the treatment of Osteogenesis Imperfecta, a rare genetic bone disorder. It is being studied in patients with Type I, III, and IV Osteogenesis Imperfecta, as well as in pediatric and adult populations. The drug is currently in Phase 3 clinical development.
Setrusumab is a monoclonal antibody that targets sclerostin, a protein that inhibits bone formation. By inhibiting sclerostin, Setrusumab aims to increase bone formation and improve bone density in patients with Osteogenesis Imperfecta. This mechanism is being evaluated in clinical trials for its potential to reduce fractures and improve bone health.
Setrusumab is being developed by Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on rare diseases. Ultragenyx is listed on the NASDAQ under the ticker symbol RARE. The company is conducting clinical trials to evaluate the safety and efficacy of Setrusumab in patients with Osteogenesis Imperfecta.
Setrusumab is currently in Phase 3 clinical development. It has received Breakthrough Therapy designation from the FDA for the treatment of Osteogenesis Imperfecta. The drug is being studied in multiple trials, including a Phase 3 trial in pediatric Japanese subjects and a Phase 2 trial in patients with Osteogenesis Imperfecta.
Setrusumab is being evaluated in several clinical trials. NCT05125809 is a Phase 2 study comparing Setrusumab to placebo in patients with Osteogenesis Imperfecta. NCT06636071 is a Phase 3 trial in pediatric Japanese subjects with Osteogenesis Imperfecta. NCT03118570 is a completed Phase 2 study in adults with Type I, III, or IV Osteogenesis Imperfecta.
Yes, Setrusumab is also known as BPS804. In clinical trials, the drug has been referred to by both names. For example, NCT03118570, a completed study in adults with Osteogenesis Imperfecta, was titled 'A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804.'