Date: 2013-12-02
Type of information: Results
phase: 3
Announcement: results
Company: Actelion (Switzerland)
Product: macitentan
Action
mechanism: endothelin receptor antagonist. Macitentan is a tissue-targeting endothelin receptor antagonist. Through complete blockade of tissular endothelin, macitentan is expected to protect tissue from the damaging effect of elevated endothelin.
Disease: reduction of the number of new digital ulcers in patients with systemic sclerosis
Therapeutic area: Autoimmune diseases
Country: USA, Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Turkey, Ukraine, UK
Trial
details: The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). (NCT01474109) The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. Other objectives include:
the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease.
the evaluation of the safety and tolerability of macitentan in these patients.
the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.
The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers (DU). Other objectives include:
the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease.
the evaluation of the safety and tolerability of macitentan in these patients.
the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.(NCT01474122)
Latest
news: * On December 2, 2013, Actelion has announced that following a scheduled meeting the independent Data Monitoring Committee (DMC) has recommended that the Phase III DUAL-2 study should be terminated. The DMC determined that there were no unexpected safety findings but that additional data are unlikely to result in a positive primary outcome measure.
The DUAL studies (DUAL-1 and DUAL-2) investigate the effect of treatment with macitentan (3mg and 10mg) compared to placebo on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers. There are no more patients in DUAL-1 receiving study treatment and this study will be completed as planned. Actelion will now collect and analyze data from both studies. Data will be made available in the future.
