At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating macitentan 3mg, macitentan 10mg, and 1 other intervention for Systemic Sclerosis and Ulcers. Completed, enrolled 289 participants across 77 sites in 18 countries.
Detailed Summary
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). 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.
Study Details
Timeline
Interventions
macitentan 3mg tablet once daily
macitentan 10mg tablet once daily
matching placebo once daily