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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02573467 | An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203 | PHASE3 | COMPLETED | 211 | — | — | Nov 2, 2015 | Feb 13, 2017 | Mar 13, 2018 | 38 | United States, Australia +8 |
| NCT01925209 | Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients | PHASE2 | COMPLETED | 251 | — | — | Sep 26, 2013 | Jan 6, 2016 | Aug 11, 2017 | 38 | United States, Australia +8 |
| NCT01423110 | Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis | PHASE2 | COMPLETED | 14 | — | — | Aug 1, 2011 | May 1, 2012 | Dec 17, 2020 | 3 | United States |
Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.
The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.
The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
Change in thigh muscle volume
| Arm | Type | Description |
|---|---|---|
| BYM338/bimagrumab 10 mg/kg | EXPERIMENTAL | Participants received BYM338 10 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338/bimagrumab 3 mg/kg | EXPERIMENTAL | Participants received BYM338 3 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338/bimagrumab 1 mg/kg | EXPERIMENTAL | Participants received BYM338 1 mg/kg administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo administered via intravenous infusion every 4 weeks for up to a maximum of 8 months after which they entered a 6-month, treatment-free follow-up period. |
| BYM338 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bimagrumab | DRUG | BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
| Placebo | DRUG | Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
| BYM338/bimagrumab | DRUG | BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. |
| BYM338 | BIOLOGICAL | - |
Inclusion Criteria: * Patients who completed the core study * Written informed consent must be obtained before any extension study assessment is performed. * Able to communicate well with the investigator. * Willing to participate for the entire duration of the extension study with commitment to fo...