NCT01925209

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

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 36 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sporadic Inclusion Body Myositis

Interventions

Type	Name	Description
DRUG	BYM338/bimagrumab	BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
DRUG	Placebo	Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.

Timeline

• Start date: 2013-09-26
• Primary completion: 2016-01-06
• Completion: 2016-01-06
• First posted: 2013-08-19
• Last updated: 2017-08-11
• Results posted: 2017-05-12

Locations

38 sites across 10 countries: United States, Australia, Belgium, Denmark, France, Italy, Japan, Netherlands, Switzerland, United Kingdom