Clinical Trial: Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body

Brief Summary: This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Effect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]

Change in thigh muscle volume


Original Primary Outcome: Measure: To assess the affect of BYM338 on Thigh Muscle Volume by MRI [ Time Frame: 8 weeks ]

Current Secondary Outcome: Effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ]

Change in muscle function measured on scale by test results


Original Secondary Outcome: Measure: To assess the effect of BYM338 on muscle function by 'Timed Get Up and Go' test [ Time Frame: 8 weeks ]

Information By: Novartis

Dates:
Date Received: August 12, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017