Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Inclusion Criteria : * Patients ≥ 18 years of age * Women of childbearing potential must use two reliable methods of contraception * Diagnosis of SSc according to the classification criteria of the American College of Rheumatology (ACR) * At least one visible, active ischemic DU at baseline * History of at least one additional recent active ischemic digital ulcer Exclusion Criteria : * DUs due to condition other than SSc * Symptomatic pulmonary arterial hypertension (PAH) * Body mass index (BMI) \< 18 kg/m\^2 * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 x upper limit of normal (ULN) * Hemoglobin \< 75% of the lower limit of the normal range * Systolic blood pressure \< 95 mmHg or diastolic blood pressure \< 50 mmHg * Severe malabsorption; any severe organ failure (e.g., lung, kidney), or any life-threatening condition * Females who are pregnant or breastfeeding or plan to do so during the course of this study * Substance or alcohol abuse or dependence, or tobacco use at any level * Treatment with phosphodiesterase-5 (PDE5) inhibitors * Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period * Patients on vasodilators, who have received treatment for less than 2 weeks prior to Screening or whose treatment has not been stable during this period * Treatment with prostanoids within 3 months * Treatment with disease modifying agents if present for less…