Date: 2015-04-16
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Actelion (Switzerland)
Product: ACT-334441
Action
mechanism: immunomodulator/ S1P1 immunomodulator.
Disease: systemic lupus erythematosus
Therapeutic area: Autoimmune diseases
Country: Belarus, Bulgaria, Georgia, Russian Federation, Ukraine, USA
Trial details:
Latest
news: * On April 16, 2015, Actelion announced that it is accelerating its clinical development efforts in the field of immunological disorders, following a broad scientific, medical and commercial evaluation of a series of its selective S1P1 receptor modulators, discovered in-house. Actelion will initiate a Phase II, prospective, multicenter, multinational, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, and tolerability of Actelion\'s second S1P1 receptor modulator in adult subjects with systemic lupus erythematosus. Approximately 64 subjects will be enrolled to receive either 0.5, 1, 2 or 4 mg/day of second S1P1 receptor modulator over a treatment period of 12 weeks. The study will be conducted at approximately 20 sites and is expected to last around 20 months.
