Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myosi
Brief Summary: This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. Patients who complete the core study and qualify for this extension study will enter Treatment Period 1, during which they will continue on the study drug which they were receiving in the core study (either one of the three BYM338 doses or placebo). Treatment Period 1 will continue until the dose of BYM338 with the best benefit-risk profile is determined and selected. The duration of Treatment Period 1 could be up to one year (but estimated to be between 6 and 8 months) and the total duration of Treatment Period 1 will depend upon the timing of selection of the dose for Treatment Period 2. Once the dose with the best benefit-risk profile is selected, all ongoing subjects (including those who have been receiving placebo) will enter Treatment Period 2 and will be switched to open-label treatment with BYM338 at the selected dose. Treatment Period 2 will continue until BYM338 is approved and commercially available in the country of the investigational site.