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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03955146




Registration number
NCT03955146
Ethics application status
Date submitted
16/05/2019
Date registered
17/05/2019

Titles & IDs
Public title
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Secondary ID [1] 0 0
FGCL-3019-091
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pamrevlumab
Treatment: Drugs - Placebo

Experimental: Pamrevlumab - Pamrevlumab 30 mg/kg by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks

Experimental: Placebo - Placebo matching to pamrevlumab by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks


Treatment: Drugs: Pamrevlumab
Pamrevlumab will be administered per dose and schedule specified in the arm description.

Treatment: Drugs: Placebo
Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Forced Vital Capacity (FVC) at Week 48
Timepoint [1] 0 0
Baseline, Week 48
Secondary outcome [1] 0 0
Time to Disease Progression
Timepoint [1] 0 0
Baseline to Week 48
Secondary outcome [2] 0 0
Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
Timepoint [2] 0 0
Baseline, Week 48
Secondary outcome [3] 0 0
Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death
Timepoint [3] 0 0
Baseline to Week 48
Secondary outcome [4] 0 0
Time to First Acute IPF Exacerbation During Study
Timepoint [4] 0 0
Baseline to Week 48
Secondary outcome [5] 0 0
Time to All-cause Mortality During Study
Timepoint [5] 0 0
Baseline to Week 48
Secondary outcome [6] 0 0
Time to First Respiratory Hospitalizations During Study
Timepoint [6] 0 0
Baseline to Week 48

Eligibility
Key inclusion criteria
Key

1. Diagnosis of IPF as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (ALAT) guidelines within the past 7 years prior to study participation.
2. High-resolution computed tomography (HRCT) scan at screening, with =10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
3. FVCpp value >45% and <95% at screening and Day 1 (prior to randomization).
4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and corrected by hemoglobin (Hb) value =25% and =90% at screening (determined locally).
5. Not currently receiving treatment for IPF with an approved therapy (that is, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.

Key
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous exposure to pamrevlumab.
2. Evidence of significant obstructive lung disease.
3. Female participants 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 other than IPF.
6. Sustained improvement in the severity of IPF during the 12 months prior to screening.
7. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
8. Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
9. Acute IPF exacerbation during screening or randomization.
10. 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. Or use of approved IPF therapies (that is, pirfenidone or nintedanib) within 1 week prior to screening.
11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/08/2023
Sample size
Target
Accrual to date
Final
393
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Mater Health Services Adult Hospital - South Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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District of Columbia
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Georgia
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Oklahoma
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Oregon
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Vermont
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Provincia De Mendoza
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Argentina
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Tucumán
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Chile
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Anhui
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China
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Beijing
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China
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China
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China
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China
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Hunan
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China
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China
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Liaoning
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China
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China
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Central
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Hong Kong
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Korea, Republic of
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Gyeonggi-do
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Busan
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Incheon
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Seoul
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Russian Federation
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Chelyabinsk
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Ekaterinburg
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Kazan
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Kemerovo
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Moscow
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Omsk
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Russian Federation
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Saint-Petersburg
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St. Petersburg
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Taiwan
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Taichung
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Taiwan
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Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
FibroGen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03955146