Phase 2
N=178
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00903331 ↗Enrolled (actual)
178
Serious AEs
32.0%
Results posted
Feb 2014
Primary outcome: Primary: Forced Vital Capacity (FVC) at Baseline and End of Period 1 — 2.74; 2.83; 2.40; 2.57 litres — p=0.9631
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACT-064992 (macitentan) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Vital Capacity (FVC) at Baseline and End of Period 1 |
2.74; 2.83; 2.40; 2.57 | 0.9631 |
| SECONDARY Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study |
59; 112; 57; 103; 44; 81 | 0.7056 |
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.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent.
- Male or female patients of at least 18 years of age (females of child-bearing potential must use a reliable method of contraception).
- IPF diagnosis within 3 years prior to randomization, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy.
Exclusion Criteria
- Interstitial lung disease due to conditions other than IPF.
- Presence of extensive honeycombing on Baseline high-resolution computed tomography (HRCT) scan performed within 3 months prior to randomization.
- Severe concomitant illness limiting life expectancy ( 1.5 x upper limit of normal.
- Hemoglobin 20 mg/day of prednisone or equivalent),
- Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine,
- Antifibrotic drugs including pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib and interferon γ,
- Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day).
- Oral anticoagulants prescribed for IPF.
- Treatment with endothelin receptor antagonists within 4 weeks prior to randomization.
- Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors).
- Treatment with Cytochrome P450 3A inducers within 4 weeks prior to randomization.
- Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
- Planned treatment, or treatment with another investigational drug within 4 weeks prior to randomization.
Data sourced from ClinicalTrials.gov (NCT00903331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.