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

Novartis

Status and phase: Completed; Phase 2

Conditions: Sporadic Inclusion Body Myositis

Treatments: Biological: Placebo; Biological: BYM338

Study type: Interventional

Funder types: Industry

Identifiers

NCT01423110

CBYM338X2205

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

BYM338

Experimental group

Treatment:

Biological: BYM338

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo