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WithdrawnNCT01346930MUSIC OLUpdated Jun 22, 2025

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

A Phase 2 interventional study of Macitentan in Idiopathic Pulmonary Fibrosis, sponsored by Actelion. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by Actelion · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • Idiopathic pulmonary fibrosis
  • IPF
  • pulmonary fibrosis
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Macitentan

    Macitentan tablet, 10 mg, once daily

    Drug: Macitentan

Interventions

  • DrugMacitentan

    10 mg, tablet, once daily

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What researchers measure

Primary outcomes

  1. Adverse Events leading to premature discontinuation of study drug

    Time frame: 5 years

Secondary outcomes

  1. 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

    Time frame: 5 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01346930
Lead sponsor
Actelion
First posted
May 4, 2011
Start date
Jul 31, 2011
Primary completion
Aug 31, 2016 (estimated)
Completion
Aug 31, 2016 (estimated)
Last update
Jun 22, 2025

Study contacts

Loic Perchenet, PhD
study chair · Actelion

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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