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

Sporadic Inclusion Body Myositis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01925209
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	September 26, 2013
Completion date	January 6, 2016

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See also
Status	Clinical Trial	Phase
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Completed	`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	Phase 3
Not yet recruiting	`NCT02735447` - Evidence Generation for Improving Life of People With sIBM: The ENGAGE Study	N/A
Completed	`NCT02317094` - Blood-flow Restricted Exercise in Inclusion Body Myositis	N/A
Completed	`NCT01519349` - Follistatin Gene Transfer to Patients With Becker Muscular Dystrophy and Sporadic Inclusion Body Myositis	Phase 1
Withdrawn	`NCT03710941` - Safety and Efficacy of REGN2477+REGN1033 in Patients With Sporadic Inclusion Body Myositis	Phase 2
Completed	`NCT01423110` - Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis	Phase 2
Completed	`NCT04421677` - Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis	Phase 1