Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
- Conditions
- Health Condition 1: null- Idiopathic Pulmonary FibrosisHealth Condition 2: J841- Other interstitial pulmonary diseases with fibrosis
- Registration Number
- CTRI/2016/02/006643
- Lead Sponsor
- FibroGen Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 136
1. Age 40 to 80 years, inclusive.
2. Diagnosis of IPF as defined by current international guidelines (Raghu, 2011). Each subject must have one of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an available HRCT scan; or (2) Possible UIP Pattern on an available HRCT scan and surgical lung biopsy within 4 years of Screening showing UIP Pattern (HRCT criteria for UIP Pattern and Possible UIP Pattern and histopathological criteria for UIP Pattern are described in protocol).
3. History of IPF of <=5 years duration with onset defined as the date of the first diagnosis of IPF by HRCT or surgical lung biopsy
4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of >=10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung, as determined by the HRCT central reader.
5. FVC percent of predicted value >=55% at Screening.
6. Female subjects of childbearing potential and male subjects with female partners of childbearing potential are required to use double barrier contraception methods during the conduct of the study and for 3 months after the last dose of study drug.
1. Female subjects who are pregnant or nursing.
2. Infiltrative lung disease other than IPF, including any of the other types of idiopathic interstitial pneumonias (Travis, 2013); lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis and connective tissue diseases.
3. HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by the HRCT central reader
4. Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as determined by the local pathologist
5. The Investigator judges that there has been sustained improvement in the severity of IPF during the 12 months prior to Screening, based on changes in FVC, diffusing capacity of the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest.
6. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the Investigator, would impact the endpoints in the protocol or otherwise preclude the subjectâ??s participation in the study.
7. History of any other respiratory, cardiovascular, renal, hepatic, metabolic, neurologic, hematologic, or other medical conditions that, in the opinion of the Investigator, would preclude the subjectâ??s participation in the study.
8. Clinically important abnormal laboratory tests (including serum creatinine >=1.5 x upper limit of normal [ULN], hemoglobin (Hb) <10 g/dL, white blood cells <3,000/mm3, platelets less than 100,000/mm3, serum total bilirubin >1.5 x ULN, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2 x ULN, or serum alkaline phosphatase >=2 x ULN.
9. Upper or lower respiratory tract infection of any type within 4 weeks of Screening.
10. Acute exacerbation of IPF within 3 months of Screening.
11. Evidence of obstructive lung disease by any of the following criteria: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio <0.70 or extent of emphysema on HRCT greater than the extent of fibrosis on HRCT.
12. DLCO <30% of predicted value.
13. High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day 1.
14. Poorly controlled chronic heart failure; clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary hypertension requiring specific treatment that, in the opinion of the Investigator, would preclude the subjectâ??s participation in the study.
15. Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal antibodies were used, the last dose of the antibody must be at least 4 weeks before Day 1 dosing.
16. Use of any investigational drugs, including any investigational drugs for IPF, within 4 weeks prior to Day 1 dosing.
17. History of cancer diagnosis of any type in the 3 years preceding Screening, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cancers.
18. Clinically significant trauma or surgical procedures within 4 weeks prior to dosing.
19. Planned elective surgery during the study including 4 weeks following the final dose of Study Drug.
20. History of allergic or anaphylactic reaction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in FVC (percent of predicted value) at Week 48Timepoint: Day 1 to Week 48
- Secondary Outcome Measures
Name Time Method 1. To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis as measured by high resolution computed tomography (HRCT) scans of the chest <br/ ><br>2. To evaluate the relationship between changes in quantified scores of pulmonary fibrosis and clinical outcomes <br/ ><br>3. To evaluate the effect of FG-3019 on progression of IPF and the frequency of respiratory-related hospitalizations and respiratory-related mortality <br/ ><br>4. To evaluate the effect of FG-3019 on health-related quality of life (HRQoL)Timepoint: 1. Week 24 and Week 48 and later time points <br/ ><br>2. Week 48 <br/ ><br>3. Week 52 <br/ ><br>4. Week 24 and Week 48 and later time points