Status:Not yet recruiting
Keywords:IPF
, Idiopathic Pulmonary Fibrosis
IRB Number:00062107
Specialty:
Sub Specialty:
The primary objective of this study is:
• To determine the effect of GS-6624 on progression free survival
Principle Investigator: Mary Scholand
Principle Department: Pulmonary
Co Investigator:
Name:Patrick Carey
Phone:801-581-5864
Email:patrick.carey@hsc.utah.edu
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in
this study.
1. Male or female subjects from 45 to 85 years of age
2. Diagnosis of definite IPF according to ATS/ERS Consensus Statement, using HRCT or
surgical lung biopsy (SLB) (both to be evaluated by a central service; the diagnosis must
be made within three years prior to screening
3. 6MWD ≥ 50 meters (164 feet): use of ≤ 6 L/min supplemental O2 is required for all
subjects
4. Able to maintain oxygen saturation of ≥ 89% while breathing room air at rest
5. Able to perform complete breath hold for diffusing lung capacity for DLCO measurement
6. Negative serum pregnancy test at screening and negative urine pregnancy test at
randomization for female subjects of childbearing potential
7. Willingness of female subjects of childbearing potential to undergo urine pregnancy tests
every 28 days
8. Females of childbearing potential must agree to use highly effective methods of
contraception from the Screening visit throughout the study period and for 30 days
following the last dose of IMP. Please refer to Section 8.11.2 for protocol recommended
methods of contraception; females of childbearing potential must have negative serum
β-hCG at Screening
9. Non-vasectomized male subjects must agree to use a highly effective method of
contraception if sexually active and refrain from sperm donation from Day 1 throughout
the study period until 90 days following the last dose of investigational medicinal product
(IMP)
10. Lactating females must agree to discontinue nursing before enrolling in the study and for
the duration of the study while receiving IMP.
11. Competency to understand the information given in the Institutional Review Board (IRB)
or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF);
subjects must sign the form prior to the initiation of any study procedures, unless the
assessment is performed as standard of care for this disease.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1. Pregnant or breastfeeding
2. Clinically significant respiratory diseases other than IPF, including asbestosis, other
pneumoconiosis or hypersensitivity pneumonitis
3. Obstructive lung disease determined by Pulmonary Function Test (PFTs) or HRCT as
follows:
• Evidence of reactive airway disease by increase in absolute forced expiratory volume
in 1 second (FEV1) of > 12% following bronchodilator challenge
• OR
• FEV1/FVC ratio < age adjusted lower limit of normal (LLN)
• OR
• Residual volume (RV) > 120% by plethysmography or significant emphysema on
HRCT defined as more emphysema than fibrosis interpreted by a central radiology
service
4. Hemoglobin corrected, not volume corrected, (DLCO) <25% of predicted normal
5. Surgical lung biopsy (SLB) showing, pneumoconiosis, hypersensitivity pneumonitis
nonspecific pneumonia or other idiopathic interstitial lung disease
6. Any collagen vascular disease
7. History of aortic aneurysm ≥ 3.5cm in diameter
8. History of cerebrovascular accident (stroke) within the preceding 26 weeks
9. Clinically significant heart disease defined as a myocardial infarction documented by an
ST elevation (STEMI) on electrocardiogram (ECG) within 6 months prior to screening,
percutaneous coronary intervention or coronary artery bypass surgery within 6 months
prior to screening, unstable angina pectoris, congestive heart failure (NYHA class III/IV
or known left ventricular ejection fraction < 25%), right heart failure, significant right
ventricular hypertrophy, or uncontrolled arrhythmia
10. Require pharmaceutical treatment for pulmonary hypertension
11. Hospitalization for acute respiratory illness < 26 weeks prior to screening
12. Aspiration pneumonia < 26 weeks prior to screening
13. Active or recent (< 4 weeks prior to enrollment) respiratory bacterial, viral, fungal, or
other infection (defined as exhibiting ongoing signs/symptoms related to the infection
and without improvement)
14. History of cancer, precancerous state (eg, familial polyposis, BRCA1, BRCA2), other
than non-melanomatous skin cancer, within 5 years prior to screening, or active work-up
for suspected lung cancer
15. History of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
16. Co-morbid condition or illness limiting life expectancy to < 2 years at time of screening
17. Major surgery, as defined by the investigator, < 30 days prior to screening or scheduled
elective surgery during the expected duration of the study
18. History or evidence of a clinically significant disorder, condition, or disease that, in the
opinion of the investigator and the Gilead medical monitor, would pose a risk to subject
safety or interfere with the study evaluations, procedures, or completion
19. Current excessive consumption of alcohol or use of illegal drugs as determined by the
investigator
Related to physiologic or organ specific abnormalities:
20. Use of supplemental O2 > 6L/min during activity
21. Inadequate organ function reflected by any of the following:
• Platelets < 100 x 109/L
• Hemoglobin < 11.0 g/dL
• Absolute Neutrophil Count (ANC) < 1.5 x 109/L
• PT/INR and PTT > 1.5 x upper limit of normal (ULN)
• AST/ALT > 3 x ULN
• Total bilirubin > 1.5 x ULN
• Serum creatinine > 2.0 mg/dL
Related to treatment for IPF or investigational drugs:
22. Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs including
pirfenidone, colchicine, cyclosporine A, TNF-α antagonists, tyrosine kinase inhibitor,
interferon-gamma, cyclophosphamide, or azathioprine < 28 days prior to randomization
are not permitted
• N-acetylcysteine is permitted provided the subject has been on stable dose for
> 12 weeks prior to screening.
• Once a subject meets the FVC criteria for PFS, the subject may, at the investigator’s
discretion be prescribed any drug that is approved for treatment of IPF in the subject’s
country of residence, including pirfenidone.
23. Chronic use (> 28 days) of moderate or high dose oral corticosteroids (equivalent of
> 10 mg of prednisone per day); short courses of higher corticosteroid doses within
1-6 months prior to randomization are permitted but limited to ≤ 28 days
24. Participation in an investigational drug or device trial < 30 days prior to screening or
within 5 times the half-life of the investigational agent in the other clinical study, if
known
25. Treatment with GS-6624 in another clinical study
26. Listed as active on a lung transplant waiting list
