CompletedPhase 2

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

United States14 participantsStarted 2011-08

Plain-language summary

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

Who can participate

Age range40 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis Exclusion Criteria: * 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

What they're measuring

Effect of BYM338 on Thigh Muscle Volume by MRI

Timeframe: 8 weeks

Trial details

NCT IDNCT01423110

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Sporadic Inclusion Body Myositis trials