Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

Long Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01346930

Acronym

MUSIC OL

Enrollment

Registered

2011-05-04

Start date

2011-07-31

Completion date

2016-08-31

Last updated

2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis, IPF, pulmonary fibrosis

Brief summary

The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).

Interventions

DRUGMacitentan

10 mg, tablet, once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signed informed consent prior to initiation of any study-related procedure. * Patients with IPF and having completed the double-blind AC-055B201/MUSIC study as scheduled, i.e., having remained in the study until the sponsor-declared end-of-study (EOS), whether or not study treatment was prematurely discontinued. * Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion criteria

* Any major violation of protocol AC-055B201/MUSIC. * Premature discontinuation of study treatment during the AC-055B201/MUSIC study due to an adverse event (AE) assessed as related to the use of macitentan, excluding events of IPF worsening. * Pregnancy or breast-feeding. * AST and/or ALT \> 3 times the upper limit of the normal range. * Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. * Known hypersensitivity to drugs of the same class as macitentan, or any of the excipients.

Design outcomes

Primary

Measure	Time frame
Adverse Events leading to premature discontinuation of study drug	5 years

Secondary

Measure	Time frame
Treatment-emergent Severe Adverse Events & occurrence of AST and/or ALT > 3 times the upper limit of the normal range up to 28 days after study drug discontinuation	5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026