RESILIENT
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III 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
IRAS ID
131148
Contact name
Michael Hanna
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-000705-23
Clinicaltrials.gov Identifier
Research summary
Sporadic inclusion body myositis (sIBM) is a very rare muscle wasting disease predominantly affecting people over the age of 50 years. Currently there are no approved treatments for this condition as no treatments have been found to slow or reverse the progression of muscle weakness in sIBM. This study will evaluate the efficacy, safety and tolerability of 3 doses of bimagrumab, a monoclonal antibody, alongside placebo, in the treatment of patients with sIBM.
Antibodies are normally made by your body’s immune system to fight infections. In recent years, a number of antibodies have been designed to work as drugs. Bimagrumab is a human antibody designed to attach to a receptor in muscle. This will stop a molecule which interferes with normal muscle growth. If this bad molecule is blocked by bimagrumab muscle cells can increase in size. Since people with sIBM lose muscle, treatment with bimagrumab could slow or stop this. Treatment with bimagrumab might increase muscle mass and might improve a person’s strength.
This is a multicentre study where neither patients nor doctors know what treatment a patient is receiving so results are objective. Patients included in the study must have a diagnosis of sIBM and not be wheelchair bound. Around 240 men and women (aged between 36-85 years) will be added into one of 4 possible study arms (bimagrumab 10 mg/kg, 3 mg/kg, 1 mg/kg or placebo as an intravenous infusion every 4 weeks). Each subject will enter a screening period of 28 days followed by a 52 week treatment period, followed by a 28-day treatment free period. Treatment beyond 52 weeks for all subjects is determined by the date the last subject completes their week 48 dose.
This study is being conducted by Novartis Pharma AG.REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/0106
Date of REC Opinion
22 Apr 2014
REC opinion
Further Information Favourable Opinion