ARTEMIS: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF).

Phase 3

Withdrawn

• Conditions: Idiopathic Pulmonary Fibrosis; lung fibrosis; 10024967

• Registration Number: NL-OMON35478
• Lead Sponsor: Gilead Sciences

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Male or females from 40 to 80 years of age
2. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on the following criteria in accordance with ATS-ERS guidelines for diagnosing IPF:
* Definite or probable UIP confirmed on SLB by core pathologist
or
* In absence of SLB, HRCT scan showing definite findings for IPF (bibasilar reticular abnormalities with minimal ground glass opacities) as determined by core review
and three of the following *minor criteria*:
* Age > 50 years
* Insidious onset of otherwise unexplained dyspnea on exertion
* Duration of illness >= 3 months
* Bibasilar, inspiratory crackles
Within 90 days of study enrollment, diagnosis must be confirmed by HRCT
3. Honeycombing <= 5% as assessed on HRCT; HRCT results will undergo a core review process (Section 7.4) to confirm diagnosis.
4. Willingness to undergo RHC at baseline and at Visit 7 or end of study (EOS)
5. Willingness and ability to comply with required monitoring of liver function every 28 days. LFTs include serum ALT, AST, alkaline phosphatase, gamma glutamyl transferase (GGT), and total bilirubin concentrations

Exclusion Criteria

1. Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of randomization):oral corticosteroids (> 20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of N-acetylcysteine (prescribed for IPF)
2. Chronic treatment with immunosuppressive, cytotoxic, or antifibrotic drugs including pirfenidone, D penicillamine, colchicine, TNF a antagonists, imatinib, interferon gamma, cyclophosphamide, cyclosporine A, or azathioprine within 30 days of randomization (Section 5.4)
3. Obstructive lung disease as determined by evidence of airflow obstruction on HRCT or physiologic criteria including:
• FEV1/FVC ratio < 0.7
• RV > 120% by plethysmography or significant (verified by radiologist) emphysema on HRCT if plethysmography not available
• Evidence of reactive airway disease by change in FEV1 of > 12% following bronchodilator challenge
4. Active or recent (<= 60 days prior to enrollment) pulmonary or upper respiratory tract infection
5. Hospitalization within 60 days of screening for an acute exacerbation of IPF
(AE IPF)
6. Chronic heart failure (NYHA class III/IV) or known left ventricular ejection fraction <25%
7. Acute or chronic impairment (other than dyspnea) which limits the ability to comply with study requirements and procedures including the 6 min-walk test.

Study & Design

• Study Type: Interventional
• Study Design: Not specified