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

• Status: Completed
• Trial end date: 2016-01-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Blocking; Antibodies, Monoclonal

Criteria

Key Inclusion Criteria:

• Diagnosed with sporadic inclusion body myositis;

• Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);

Key Exclusion Criteria:

• Must not have other conditions that significantly limit ability to move around;

• Must not be using corticosteroids. Must not have used systemic corticosteroid (at daily dose >=10mg prednisone) for the past 3 months;

• Must meet cardiovascular requirements;

• Must not be pregnant or nursing;

• Must not have a chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc.);