A double blind, randomized, placebo-controlled study to evaluate safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis
Trial ID or NCT#
Status
Purpose
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.
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