None listed
Conditions
Interventions
Arm A: pamrevlumab, 30 mg/kg IV Type of group
Pamrevlumab, 30 mg/kg IV, Day 1 and every 3 weeks thereafter with the last dose at Week 48
Group name:Arm B: Matching placebo IV. Type of group
Arm B: Matching placebo IV, Day 1 and every 3 weeks thereafter with the last dose at Week 48
Sponsors
FibroGen, Inc.,
Eligibility
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 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 <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung. NOTE: this requires confirmation by an Independent Radiology Imaging Review Group, prior to randomization. If a recent HRCT scan (within 3 months prior to screening) is available, it can be utilized for screening purposes, provided it is submitted and evaluated by the Independent Radiology Imaging Review Group, is adhering to the imaging parameters detailed in the Imaging Core Manual (ICM), and is using the same accredited scanner as the on-study HRCT scans. 5. FVCpp value ≥50% and ≤80% at Screening and Day 1. 6. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by Hb value ≥30% and ≤90% at Screening (determined locally). 7. Both FVC and DLCO testing must be representative of the IPF underlying disease (i.e. have been obtained in absence of an acute respiratory event [e.g. lung infection, cold] or other events that are known to affect PFT testing results [e.g., broken rib, chest pain, other]). 8. Previously treated with an approved IPF therapy (i.e., pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country. NOTE: no subject should discontinue approved therapy for the purpose of enrolling in this study. 9. Male subjects with partners of childbearing potential and female subjects of childbearing potential (including those <1 year postmenopausal) must use double barrier contraception methods during the conduct of the study, and for 3 months after the last dose of study drug. Women not of childbearing potential are defined as: a. Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR b. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR c. Have a congenital or acquired condition that prevents childbearing. 10. Able to understand and sign a written informed consent form.
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. 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. 17. Any condition (other than IPF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:As part of the spirometry evaluation Measure:Proportion of subjects with Disease Progression, defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first. Timepoints:From baseline to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:As part of the spirometry evaluation Measure:Change in FVC (L) Timepoints:From baseline to Week 52 ; Outcome name:As part of the spirometry evaluation Measure:Change in absolute and relative FVCpp Timepoints:From baseline to Week 52 ; Outcome name:Clinical outcomes and spirometry evaluation Measure:Respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first Timepoints:During the study ; Outcome name:High resolution computed tomography (HRCT) Measure:Change in Quantitative Lung Fibrosis (QLF) volume Timepoints:From baseline to Week 52 ; Outcome name:St. George’s Respiratory Questionnaire (SGRQ) Measure:Change in St. George’s Respiratory Questionnaire (SGRQ) score Timepoints:From baseline to Week 48 ; Outcome name:University of California San Diego – Shortness of Breath Questionnaire (UCSD-SOBQ) Measure:Change in University of California San Diego – Shortness of Breath Questionnaire (UCSD-SOBQ) score Timepoints:From baseline to Week 48 ; Outcome name:Leicester Cough Questionnaire (LCQ) Measure:Change in Leicester Cough Questionnaire (LCQ) Timepoints:From baseline to Week 48 ; Outcome name:Clinical outcomes and High Resolution Computerized Tomography (HRCT) Measure:All-cause mortality and Acute IPF exacerbations Timepoints:During the study | — |
Countries
Brazil, Colombia, Czech Republic, Denmark, Dominican Republic, France, Georgia, Germany, Hungary, India, Ireland, Italy, Lebano, Mexico, Nederland, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kindgdom
Contacts
Public ContactElvira Mogrovejo
WorldWide Clinical Trials Peru S.R.L. -W.C.T. Peru S.R.L.
Outcome results
None listed