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Clinical Trials

Date: 2011-08-29

Type of information: Results

phase: 2

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, specifically in the cardiovascular system.

Disease: idiopathic pulmonary fibrosis

Therapeutic area: Respiratory diseases - Lung diseases

Country: Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey, USA

Trial details:

MUSIC (Macitentan USe in an Idiopathic pulmonary fibrosis Clinical study) a double-blind, randomized, multicenter study evaluated the efficacy and safety of the 10 mg dose of macitentan in patients with idiopathic pulmonary fibrosis. The study enrolled 178 patients, who were exposed to either macitentan or placebo with over 75% of patients exposed for at least 12 months and with a mean exposure of over 14 months. (NCT00903331)

Latest news:

Actelion has announced that the exploratory Phase II study with macitentan in patients with idiopathic pulmonary fibrosis (IPF) shows a promising safety and tolerability profile of macitentan, no difference being observed between placebo and macitentan with regard to liver enzyme elevations. The primary endpoint of the MUSIC study, forced vital capacity, was not met. The company will not initiate a Phase III IPF program. Actelion will analyze the study data in detail to understand certain observations in favor of macitentan such as reduced cough and fewer reported cases of pulmonary hypertension (PH). Following discussions with clinical experts in the field, Actelion will present full study data through scientific publications and decide on potential future exploratory efforts. The safety set comprised 178 patients (randomized 2:1), who received at least one dose of study treatment. Exposure to study treatment was similar in each group, with an average duration of 14.3 months in the macitentan group (n = 119) and 15.4 months in the placebo group (n = 59).
The dual endothelin receptor antagonist macitentan in this patient population was generally well tolerated. Most notably, there was no difference in liver enzyme elevations between macitentan and placebo. Elevations of liver alanine or aspartate aminotransferases greater than three times the upper limit of normal were observed in 4 macitentan-treated patients (3.4%) and 3 placebo recipients (5.1%).
As in other IPF studies with endothelin receptor antagonists, class-related adverse events more frequent on macitentan than placebo were those related to fluid retention (with only one patient discontinuing study treatment) and decrease in hemoglobin, with these changes judged to be not clinically relevant.
In contrast to the tolerability profile of other endothelin receptor antagonists in previous clinical studies, there were no relevant findings of headache, hypotension, nasopharyngitis, rhinitis and hot flush.

Is general: Yes