Safety and Efficacy of BAF312 in Dermatomyositis

• Status: Terminated
• Trial end date: 2016-02-17
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated 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 was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Siponimod

Criteria

Key Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.

• Patients who have been defined as "definite" or "probable" based on the criteria of Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at least 3 months before screening

• Patients must have active disease as defined by muscle weakness

• 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 12 months prior to screening visit

Key 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