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Trial details
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Current status:
Approved
|
Date registered:
11/10/2021
|
Date last updated:
01/03/2021
Trial version(s)
History: 18/08/2020
Current: 18/08/2020
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Main Information
Primary registry identifying number
LBCTR2020094566
Protocol number
FGCL-3019-095
MOH registration number
30220/2020
Trial already registered with the MoPH
Study registered at the country of origin
No
Type of registration
Prospective
Date of registration in national regulatory agency
08/09/2020
Primary sponsor
FibroGen Inc.
Primary sponsor: Country of origin
United States of America
Public title
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
Scientific title
Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)
Acronym
Brief summary of the study: English
This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis
Brief summary of the study: Arabic
هذه تجربة Phase 3 لتقييم فعالية وسلامة الحقن الوريدي ل-30 مجم / كجم من Pamrevlumab كل 3 أسابيع مقارنة بالدواء الوهمي عند الأشخاص المصابين بالتليف الرئوي مجهول السبب
Health conditions/problem studied: Specify
Idiopathic Pulmonary Fibrosis
Interventions: Specify
*Drug: Pamrevlumab (FG-3019) Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks *Drug: Placebo Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Key inclusion and exclusion 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 samples (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.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
40
Key inclusion and exclusion criteria: Age maximum
85
Key inclusion and 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 <0.70, or (2) extent of emphysema greater than the extent of fibrosis on HRCT. NOTE: this requires confirmation by an Independent Radiology Imaging Review Group, prior to randomization. 3. Female subjects who are pregnant or nursing. 4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study. 5. Interstitial lung disease (ILD) other than IPF, including but not limited to any of the other types of idiopathic interstitial pneumonia; 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, infectious diseases (i.e. TB) and connective tissue diseases. In cases of uncertain diagnosis, serological testing and/or review by the multi-disciplinary team should be performed to confirm the diagnosis of IPF vs. other types of ILD. 6. Sustained improvement in the severity of IPF during the 12 months prior to Screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest. 7. 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 primary protocol endpoint or otherwise preclude the subject’s participation in the study. 8. Medical conditions (e.g. MI/stroke within the past 6 months), or logistical challenges that in the opinion of the Investigator preclude the subject’s adequate participation in the study. 9. Poorly controlled chronic heart failure (NYHA Class 3 or above); clinical diagnosis of cor pulmonale requiring specific treatment; or severe pulmonary arterial hypertension requiring specific treatment that, in the opinion of the Investigator, would preclude the subject’s participation in the study. 10. 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. 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 the 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) that is likely to result in the death of the patient within the next year. 18. The Investigator judges that the subject will be unable to fully participate in the study and complete it for any reason, including the inability to comply with study procedures and treatment, addiction, or any other relevant medical or psychiatric conditions.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Safety and Efficacy
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Pamrevlumab (FG-3019)
Type of IMP
Others
Type of IMP: Specify
Biological
Pharmaceutical class
Pamrevlumab is a recombinant fully human immunoglobulin G1 (IgG) kappa monoclonal antibody that binds to connective tissue growth factor (CTGF)
Therapeutic indication
Idiopathic Pulmonary Fibrosis
Therapeutic benefit
Pamrevlumab is a recombinant fully human immunoglobulin G1 (IgG1) kappa monoclonal antibody which inhibits the activity of connective tissue growth factor (CTGF).
Biospecimen retention
Samples without DNA
Biospecimen description
Samples with DNA is optional
Target sample size
7
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/10/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
30/06/2023
Recruitment status
Pending
Date of completion
31/03/2023
IPD sharing statement plan
No
IPD sharing statement description
Confidential Info
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
ClinicalTrials.gov
NCT04419558
EU Clinical Trials Register
2020-000697-22
Sources of Monetary or Material Support
Name
FibroGen Inc.- USA
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Dr. Samer
Kabbani
Beirut
Lebanon
9611744772
kabbanisamer@hotmail.com
Rafik Hariri University Hospital
Scientific
Dr. Moussa
Riachi
Beirut
Lebanon
9611615075
moussariachy@gmail.com
Hotel Dieu de France Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France Hospital
Dr. Moussa Riachy
Pulmonary Medicine
Approved
Rafic Hariri University Hospital
Dr. Samer Kabbani
Cardiology
Approved
American University of Beirut Medical Center
Dr. Pierre Bou Khalil
Internal Medicine
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
05/05/2020
Pr. Sami Richa
cue@usj.edu.lb
+9611421229
Rafic Hariri University Hospital
03/06/2020
Dr. Iyad Issa
N/A
+9611830000
American University of Beirut Medical Center
30/12/2020
Dr. Fuad Ziyadeh
NA
+9611350000
Countries of Recruitment
Name
France
Lebanon
Italy
Hungary
Netherlands
Germany
United Kingdom
Spain
Denmark
Czech Republic
Georgia
Hungary
Health Conditions or Problems Studied
Condition
Code
Keyword
Idiopathic Pulmonary Fibrosis
Other diseases of pulmonary vessels (I28)
Idiopathic Pulmonary Fibrosis IPF Idiopathic Interstitial Pneumonia Interstitial Lung Disease Lung Fibrosis, Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes, Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial
Interventions
Intervention
Description
Keyword
Drug
Pamrevlumab
FG-3019
Drug
Placebo
N/A
Primary Outcomes
Name
Time points
Measure
Proportion of subjects with Disease Progression
Baseline to Week 52
absolute FVC percent predicted (FVCpp) decline of ≥10% or death
Key Secondary Outcomes
Name
Time points
Measure
Change in FVC (L)
Baseline to Week 52
FVC (L)
Change in FVCpp
Baseline to Week 52
Change in FVCpp (absolute and relative)
Composite of clinical outcomes
Baseline to Week 52
Respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first
Respiratory hospitalizations
Baseline to Week 52
Respiratory hospitalizations
Change in Quantitative Lung Fibrosis (QLF) volume
Baseline to Week 52
Quantitative Lung Fibrosis (QLF) volume
Change in St. George’s Respiratory Questionnaire (SGRQ) score
Baseline to Week 48
St. George’s Respiratory Questionnaire (SGRQ) score
Change in University of California San Diego – Shortness of Breath Questionnaire (UCSD-SOBQ) score
Baseline to Week 48
University of California San Diego – Shortness of Breath Questionnaire (UCSD-SOBQ) score
Change in Leicester Cough Questionnaire (LCQ)
Baseline to Week 48
Leicester Cough Questionnaire (LCQ)
All-cause mortality
During whole study duration
Death
Acute IPF exacerbations
During whole study duration
N/A
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
field adjusted that it is not registered at country of origin USA
10/09/2020
AUBMC added to the study sites
01/03/2021
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