RESILIENT EXTENSION STUDY
Research type
Research Study
Full title
Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis
IRAS ID
173718
Contact name
Michael Hanna
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-001411-12
Duration of Study in the UK
2 years, 0 months, 25 days
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.
The main purpose of this multicentre extension study is to measure how safe and well tolerated BYM338 is in the long term. All patients will have completed the CBYM338B2203 study on treatment. Each patient who signs consent and meets inclusion criteria will undergo examinations to determine that they are eligible to join the study. Eligible Patients will enter treatment period 1 and receive double blind treatment according to the treatment arm in the CBYM338B2203 study (bimagrumab 10 mg/kg, 3mg/kg, 1 mg/kg or placebo as an intravenous infusion every 4 weeks) for 52 weeks. Post treatment period 1 patients will enter treatment period 2, this consists of 52 weeks of intravenous infusion every 4 weeks at the selected dose of BYM338.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0406
Date of REC Opinion
18 Oct 2015
REC opinion
Further Information Favourable Opinion