Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis MUSIC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 178
Healthy volunteers: no

Brief summary:
The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF).

The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

Detailed description:
The study included two treatment periods: Period 1 (fixed duration) from randomization up to the primary endpoint evaluation (Month 12 or earlier in case of premature discontinuation of study drug) and Period 2 (variable duration) from the primary endpoint evaluation visit up to the end of study (EOS). EOS occurred when the last patient randomized and not prematurely discontinued completed Period 1.

Arms:
arm 1: ACT-064922 tablet (macitentan), 10 mg, once daily arm 2: Matching placebo, once daily

Interventions: intervention 1: ACT-064992 (macitentan) intervention 2: Placebo
Intervention descriptions: intervention 1: ACT-064992 (macitentan) tablet, 10 mg, once daily intervention 2: matching placebo, once daily

Protocol document: