A Double Blind, Randomized, Placebo-controlled Study to Evaluate, Safety, Tolerability, Efficacy and Preliminary Dose-response of BAF312 in Patients With Active Dermatomyositis
This study investigates the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study is composed of 2 periods: a double-blind period I with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period II in which BAF312 will be administered at the dose of 2 mg daily .
Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. – Male and female patients between 18 – 65 (inclusive) years of age who have been defined as “definite” or “probable” based on the criteria of Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at least 12 months before screening – Patients must have active disease as defined by dermatomyositis skin rash AND Muscle weakness – Patients must have responded inadequately to previous standard of care or have demonstrated significant toxicity or intolerance to such therapies. – Patients may be on a stable dose of corticosteroid (up/equal to 20 mg once daily prednisone equivalent) – Patients currently treated with oral or subcutaneous MTX must have been a stable dose of no more/equal to than 25 mg per week – Patients currently treated with Azathioprine must have been a stable maintenance dose of no more/equal to 3 mg/kg/day – Negative cancer screening conducted in the 6 months prior to screening visit Exclusion Criteria – Dermatomyositis patients having overlap myositis or any other type of myositis including paraneoplastic myositis, drug-induced myopathy, necrotizing myositis – Preexisting severe cardiac or pulmonary conditions, malignancy of any organ system or significant eye diseases. – Uncontrolled diabetes mellitus or diabetes complicated with organ involvement. – Pregnant or nursing (lactating) women – Other protocol-defined inclusion/exclusion criteria apply.