Safety and Efficacy of BAF312 in Dermatomyositis
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Active Dermatomyositis
In brief
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 .
Key facts
- Study ID
- NCT02029274
- Run by
- Novartis Pharmaceuticals
- People needed
- 17
- Starts
- 2013-08-25
- Expected to finish
- 2016-02-17
- Last updated by the study team
- 2021-01-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Los Angeles, California, United States
- Novartis Investigative Site — Orange, California, United States
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Kansas City, Kansas, United States
- Novartis Investigative Site — Boston, Massachusetts, United States
- Novartis Investigative Site — Prague, Czech Republic, Czechia
- Novartis Investigative Site — Chiba, Chiba, Japan
- Novartis Investigative Site — Sendai, Miyagi, Japan
Full record on ClinicalTrials.gov
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