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

Status:	Active, not recruiting
Conditions:	Infectious Disease, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	36 - 85
Updated:	4/21/2016
Start Date:	September 2013
End Date:	March 2016

Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate Efficacy, Safety, Tolerability of i.v. BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility in Sporadic Inclusion Body Myositis Patients

To evaluate 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)

Inclusion Criteria:

- Diagnosed with sporadic inclusion body myositis;

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

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); Other protocol-defined inclusion/exclusion criteria may apply

We found this trial at

sites

Novartis

Portland, Oregon 97228