Idiopathic Pulmonary Fibrosis MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
FibroGen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 40 to 85 years, inclusive, at screening initiation. 2. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018). 3. IPF diagnosis within the past 7 years, with onset defined as the date of the first recorded diagnosis of IPF by HRCT and/or surgical lung biopsy (SLB), or other appropriate tissue sample (e.g., cryobiopsy) in the medical history. 4. Interstitial pulmonary fibrosis defined by HRCT scan at screening, with evidence of =10% to =65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: 1. Previous exposure to pamrevlumab. 2. Evidence of significant obstructive lung disease by any of the following criteria: (1) forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio 1.5 x ULN, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2 x ULN, or serum alkaline phosphatase =2 x ULN. 11. Ongoing acute IPF exacerbation, or suspicion of such process by the Investigator, during screening or randomization, including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening. 12. High likelihood of lung transplantation (in the opinion of the Investigator) within 6 months after Day 1. 13. Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. 14. Daily use of PDE-5 inhibitor drugs (e.g. sildenafil, tadalafil), except for treatment of severe pulmonary artery hypertension. 15. Any current malignancy (this does not include localized cancer such as basal or squamous cell carcinoma of skin). Any history of malignancy likely to result in mortality, or requiring significant medical or surgical intervention within the next year. 16. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient. 17. Any condition (other than IPF) that is likely to result in the death of the patient within the next year. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this trial is to evaluate the efficacy and safety of 30 mg/kg IV infusions of pamrevlumab as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis. ;Secondary Objective: Not Applicable;Primary end point(s): Change in FVC (L);Timepoint(s) of evaluation of this end point: From baseline at Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Time to disease progression, defined as absolute FVC percent predicted (FVC pp) decline of =10% or death, whichever occurs first 2-Change in Quantitative Lung Fibrosis (QLF) volume from baseline at Week 48 3-Time to any component of the clinical composite endpoint, whichever occurs first: acute IPF exacerbation, respiratory hospitalization, or death 4-Time to first acute IPF exacerbation during study 5-Time to all-cause mortality during study 6-Time to first respiratory hospitalization during study ;Timepoint(s) of evaluation of this end point: 1- During the study 2- From baseline at Week 48 3- During the study 4- During the study 5- During the study 6- During the study | — |
Countries
Argentina, Brazil, China, Colombia, Czechia, Czech Republic, Denmark, Dominican Republic, France, Georgia, Germany, Hungary, Ireland, Italy, Korea, Republic of, Lebanon, Mexico, Netherlands, Peru, Poland, Serbia, Spain, Switzerland, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
FibroGen, Inc.
Outcome results
None listed