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

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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
13
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Boston, Massachusetts 02118
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Baltimore, Maryland 21287
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Boston, Massachusetts 02118
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Colubus, Ohio 43221
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Dallas, Texas 75216
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Houston, Texas 77030
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Kansas City, Kansas 66160
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Miami, Florida 33136
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Orange, California 92868
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Phoenix, Arizona 85012
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Sacramento, California 95825
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St. Leonards, New South Wales 2065
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