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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sporadic Inclusion Body Myositis

In brief

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

Key facts

Study ID

NCT01423110

Run by

Novartis Pharmaceuticals

People needed

14

Starts

2011-08-01

Expected to finish

2012-05-01

Last updated by the study team

2020-12-17

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

You may not qualify if…

• Unable to walk at least 3 meters without assistance from another person
• Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
• patients with a history or presence of renal impairment and/or liver disease
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Scottsdale, Arizona, United States
• Novartis Investigative Site — Kansas City, Kansas, United States
• Novartis Investigative Site — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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