DUAL 2

• Research type

  Research Study

• Full title

  Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis.

• IRAS ID

  87442

• Contact name

  Chris Denton

• Sponsor organisation

  Actelion Registration Ltd

• Eudract number

  2010-022969-95

• ISRCTN Number

  isr

• Research summary

  This study is a prospective, randomised, double-blind, placebo controlled, multicentre, parallel group, phase III study in patients with digital ulcers associated with systemic sclerosis (scleroderma). Study participants will receive either placebo or one of two doses (3 or 10mg) of Macitentan. The study is designed to assess the safety and effectiveness of Macitentan. At least 285 patients will be enrolled in 3 groups (95 patients per group). The screening period will last up to 14 days and this is then followed by treatment period 1 which lasts for 16 weeks. All patients completing period 1 will continue on their original randomised treatment during period 2 until the last randomised patient has completed treatment period 1 when the end of treatment visit will occur for all patients. All patients will be followed up until the end of study visit (30 days after end of treatment visit). Therefore the study duration will be up to 25 months for the first patient enrolled and approximately 5 months for the last patient enrolled. The study is designed to investigate the effects of Macitentan on the number of new digital ulcers and ongoing digital ulcers in patients with systemic sclerosis. The effects of digital ulcer disease will also be measured by investigating hand functionality, digital ulcer burden and digital ulcer complications.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1986

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Favourable Opinion