Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study

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 - MUSIC OL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024211-13-SE

Enrollment

178

Registered

2011-04-05

Start date

2011-05-26

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

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, 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 113

Exclusion criteria

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
Secondary Objective: N/A;Main Objective: To assess the long-term safety and tolerability of macitentan in patients with Idiopathic Pulmonary Fibrosis;Primary end point(s): - AEs leading to premature discontinuation of study drug. - Treatment-emergent SAEs up to 28 days after study drug discontinuation. - Occurrence of liver aminotransferase (ALT and/or AST) abnormality (> 3 and 5 and 8 X ULN) up to 28 days after study drug discontinuation.;Timepoint(s) of evaluation of this end point: - 6-monthly safety visit - Liver aminotransferase and pregnancy (if applicable): monthly - Follow-up period 28 days after treatment discontinuation	—

Measure

Time frame

Secondary Objective: N/A;Main Objective: To assess the long-term safety and tolerability of macitentan in patients with Idiopathic Pulmonary Fibrosis;Primary end point(s): - AEs leading to premature discontinuation of study drug. - Treatment-emergent SAEs up to 28 days after study drug discontinuation. - Occurrence of liver aminotransferase (ALT and/or AST) abnormality (> 3 and 5 and 8 X ULN) up to 28 days after study drug discontinuation.;Timepoint(s) of evaluation of this end point: - 6-monthly safety visit - Liver aminotransferase and pregnancy (if applicable): monthly - Follow-up period 28 days after treatment discontinuation

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Australia, Canada, Germany, Israel, Slovenia, South Africa, Spain, Sweden, Turkey, United States

Contacts

Public ContactGlobal Medical Information

ACTELION Pharmaceuticals Ltd.

medinfo_ch@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026