At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 10 enrolled
Drug / intervention
BYM338 (Bimagrumab)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Long-term Study to Evaluate the Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
In Brief
A Phase 3 clinical trial evaluating BYM338 (Bimagrumab) for Sporadic Inclusion Body Myositis (sIBM). Completed, enrolled 10 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSporadic Inclusion Body Myositis (sIBM)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedSep 2014
Primary CompletionAug 2016
TodayJul 2026
First PostedSep 26, 2014
Enrollment StartMar 11, 2014
Primary CompletionAug 23, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.8 years ago
Interventions
BYM338 (Bimagrumab)drug