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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02152761 | Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery | PHASE2 | COMPLETED | 251 | — | — | Sep 16, 2014 | Oct 25, 2018 | Aug 19, 2020 | 53 | United States, Argentina +17 |
Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed
| Arm | Type | Description |
|---|---|---|
| bimagrumab 700 mg | EXPERIMENTAL | Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab high dose administered via intravenous infusion starting Day 1 until Week 20 |
| bimagrumab 210 mg | EXPERIMENTAL | Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria were treated with the bimagrumab medium dose administered via intravenous infusion starting Day 1 until Week 20 |
| placebo | PLACEBO_COMPARATOR | Approximately 70 patients who met all inclusion criteria and none of the exclusion criteria received matching placbo administered via intravenous infusion starting Day 1 until Week 20 |
| Bimagrumab 70 mg | EXPERIMENTAL | Approximately 35 patients who met all inclusion criteria and none of the exclusion criteria were treated with bimagrumad low dose administered via intravenous infusion starting Day 1 until Week 20 |
| Name | Type | Description |
|---|---|---|
| bimagrumab | DRUG | Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20. |
| placebo | OTHER | Matching placebo was administered as intravenous infusion starting on Day 1 until week 20. |
Inclusion Criteria: Must have X-ray confirmed successful hip fracture repair; Must have completed surgical wound healing; Ability to walk a specified distance with or without a walking aid; Must weigh at least 35 kg. Exclusion Criteria: Must not have history of any other lower limb fractures in t...