Safety and Efficacy of BAF312 in Dermatomyositis
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 .
Timeline
- Start
- 2013-08-25
- Primary completion
- 2016-02-17
- Completion
- 2016-02-17
Outcome
Missed primary endpoint
Stopped: “The study was terminated prematurely after an interim analysis for futility. The study did not provide any evidence for efficacy of BAF312 in dermatomyositis.”
registry analysis (unspecified test); BAF312 0.5mg vs Placebo; p = 0.9621; Mean Difference (Net) 0.551 (95% CI -22.447 to 23.549); Repeated measures analysis NCT02029274 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAF312 | Unknown | 0.5 mg | Oral |
| Subject | BAF312 | Unknown | 2 mg | Oral |
| Subject | BAF312 | Unknown | 10 mg | Oral |