Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

Summary

This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).

Timeline

Start

2013-09-26

Primary completion

2016-01-06

Completion

2016-01-06

Outcome

Missed primary endpoint

paper At week 52, 6MWD change from baseline did not differ between any bimagrumab dose and placebo PMID 31397289 ↗

registry analysis (superiority or other test); BYM338/Bimagrumab 10 mg/kg vs Placebo; p = 0.2210; Mean Difference (Net) 17.59 (99% CI -19.63 to 54.80); mixed model repeated measures NCT01925209 ↗

Publications

• Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Katsuno M, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Auberson LZ, Wu M, de Vera A, Papanicolaou DA, Amato AA; RESILIENT Study Group. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet Neurol. 2019 Sep;18(9):834-844. doi: 10.1016/S1474-4422(19)30200-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimagrumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Bimagrumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Bimagrumab	Monoclonal antibody	10 mg/kg	Intravenous

Indications