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

Novartis Pharmaceuticals14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sporadic Inclusion Body Myositis

Interventions

BYM338BIOLOGICAL

PlaceboBIOLOGICAL

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Novartis Investigative Site

Scottsdale, Arizona, United States

Novartis Investigative Site

Kansas City, Kansas, United States

Novartis Investigative Site

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Effect of BYM338 on Thigh Muscle Volume by MRI

Change in thigh muscle volume

Time frame: 8 weeks

Secondary Outcomes

Effect of BYM338 on muscle function by 'Timed Get Up and Go' test

Change in muscle function measured on scale by test results

Time frame: 8 weeks

Data from ClinicalTrials.gov

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