Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis

In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

Main Inclusion Criteria:

• Systemic Sclerosis (SSc), diffuse or limited.
• SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.

Main Exclusion Criteria:

• Digital ulcers due to conditions other than SSc.
• Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
• Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
• Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
• Treatment with inhaled or oral prostanoids one month prior to randomization.
• Previous treatment with bosentan.