ARTEMIS-IPF: 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) - ARTEMIS-IPF
- Conditions
- Idiopathic pulmonary fibrosis (IPF)MedDRA version: 9.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
- Registration Number
- EUCTR2008-004405-34-GB
- Lead Sponsor
- Gilead Sciences Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
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
6.Forced vital capacity (FVC) > 50 to = 95% of predicted with a ratio of
FEV1 (L) / FVC (L) = 0.7. Pulmonary function tests must be completed no more than 90 days before enrollment
7.Ability to perform and complete 6MWT at screening
8.Negative serum pregnancy test at screening and negative urine pregnancy test at randomization for female subjects of childbearing potential (defined in Section 6.3).
9.Female subjects of childbearing potential must be willing to use at least two reliable methods of contraception throughout their participation in the study and 30 days after discontinuation of IMP unless the subject has had a tubal sterilization, is postmenopausal, or has a Copper T 380A intrauterine device (IUD) or LNg 20 IUD inserted, in which case no other contraception is needed. Subjects of childbearing potential must also be willing to undergo pregnancy tests every 28 days.
10.Male subjects must be capable of understanding and acknowledging potential risks of testicular tubular atrophy and infertility associated with taking this IMP as described in the Informed Consent Form (ICF)
11.Competency to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved ICF. Subjects must sign the form prior to the initiation of any study procedures, unless the assessment is performed in the routine care for this disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Diagnosis of an ILD or restrictive lung disease other than UIP or IPF
2.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
3.Evidence of sustained improvement of IPF condition defined as improvement from pre therapy PFTs observed with two or more successive post therapy PFTs over the year prior to randomization
4.Condition(s) that is or are a contraindication for RHC including:
•Tricuspid or pulmonary valve stenosis
•Prosthetic tricuspid or pulmonary valve
•Right atrial or right ventricular masses
•Cyanotic heart disease
•Allergy to latex or catheter material
•Previous pneumonectomy.
5.Active or recent (= 60 days prior to enrollment) pulmonary or upper respiratory tract infection
6.Hospitalization within 60 days of screening for an acute exacerbation of IPF
(AE IPF)
7.Chronic heart failure (NYHA class III/IV) or known left ventricular ejection fraction < 25%
8.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)
9.Acute or chronic impairment (other than dyspnea) which limits the ability to comply with study requirements and procedures including the 6MWT
10.Treatment with ambrisentan in a clinical study or with commercial product
11.Treatment with an approved or experimental ERA within 30 days prior to randomization
12.Chronic use of sildenafil or other phosphodiesterase type 5 (PDE 5) inhibitor for pulmonary hypertension
13.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)
14.Prior ERA treatment discontinued for any toxicity
15.ALT or AST > 1.5 × ULN at screening
16.Hemoglobin concentration < 75% of LLN at screening
17.Serum creatinine = 2.5 mg/dL (221 µmol/L) or subject requires hemodialysis, peritoneal dialysis or hemofiltration
18.Systolic blood pressure < 85 mmHg
19.History of malignancies within the past 5 years, with the exception of basal cell carcinoma of the skin or successfully treated in situ carcinoma of the cervix
20.Female who is pregnant or nursing
21.Known history of alcohol abuse within 1 year of enrollment
22.Participation in a clinical study and receiving another investigational drug or device (not placebo) within 28 days of screening
23.Comorbid condition or illness limiting life expectancy to < 1 year at time of screening
24.Serious or active medical or psychiatric condition which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method