Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

Summary

This study is an open-label, long-term study for those patients who participated in the prior proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing. However due to lack of efficacy in patients with sIBM, the study was terminated early.

Timeline

Start

2014-03-11

Primary completion

2016-08-23

Completion

2016-08-23

Publications

• Sivakumar K, Cochrane TI, Sloth B, Ashar H, Laurent D, Tanko LB, Amato AA. Long-term safety and tolerability of bimagrumab (BYM338) in sporadic inclusion body myositis. Neurology. 2020 Oct 6;95(14):e1971-e1978. doi: 10.1212/WNL.0000000000010417. Epub 2020 Jul 20.

Drugs

Indications