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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02345070
Registration number
NCT02345070
Ethics application status
Date submitted
19/01/2015
Date registered
26/01/2015
Date last updated
24/03/2022
Titles & IDs
Public title
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
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Scientific title
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study
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Secondary ID [1]
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2014-003933-24
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Secondary ID [2]
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DRI11772
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Universal Trial Number (UTN)
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Trial acronym
ESTAIR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAR156597
Treatment: Drugs - placebo
Placebo Comparator: Placebo qw - Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
Experimental: SAR156597 200 mg q2w - Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
Experimental: SAR156597 200 mg qw - Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Treatment: Drugs: SAR156597
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Treatment: Drugs: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
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Assessment method [1]
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FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [1]
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Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52
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Assessment method [1]
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Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute percent predicted FVC greater than or equal to (>=) 10%, decrease in absolute percent predicted Carbon monoxide diffusing lung capacity >=15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200 mg arms.
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Timepoint [1]
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From randomization to disease progression (up to Week 52)
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Secondary outcome [2]
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Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52
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Assessment method [2]
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All-cause mortality was considered for this outcome measure which was defined as the time from randomization to the date of death. The median time to event was not estimated because the number of all cause mortality was too low in the SAR156597 200 mg arms.
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Timepoint [2]
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From randomization up to Week 52
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Eligibility
Key inclusion criteria
Inclusion criteria :
- Adult male or female participants.
- Documented diagnosis of IPF according to the current 2011 American Thoracic
Society/European Respiratory Society/Japanese Respiratory Society/ American Latin
Thoracic Association (ATS/ERS/JRS/ALAT) guidelines.
- Signed written informed consent.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Age less than or equal to 40 years.
- IPF disease diagnosis greater than 5 years.
- Forced vital capacity (FVC) less than (<) 40 percent (%) of predicted value.
- Carbon monoxide diffusing lung capacity (DLCO) corrected for hemoglobin <30% of
predicted value.
- Severe chronic obstructive bronchitis as characterized by forced expiratory volume in
1 second /forced vital capacity (FEV1/FVC) <0.70.
- Need for 24 hours of oxygen therapy or oxygen saturation <88% after 10 minutes
breathing ambient air at rest.
- Known diagnosis of significant respiratory disorders other than IPF.
- Pulmonary artery hypertension requiring a specific treatment.
- Currently listed and/or anticipated for lung transplantation within the next 6 months
(on an active list).
- History of vasculitis or connective tissue disorders.
- Known human immunodeficiency virus or chronic viral hepatitis.
- Participants with active tuberculosis or incompletely treated latent tuberculosis
infection.
- Use of any cytotoxic/immunosuppressive agent including but not limited to
azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to
screening.
- Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab,
golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24
weeks for rituximab and 24 months for alefacept).
- Use of any investigational drug within 1 month of screening, or 5 half-lives, if known
( whichever was longer), or within 12 weeks for stem cell therapy.
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/08/2017
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Sample size
Target
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Accrual to date
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Final
327
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036005 - Camperdown
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Recruitment hospital [2]
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Investigational Site Number 036004 - Darlinghurst
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Investigational Site Number 036002 - Frankston
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Investigational Site Number 036003 - Murdoch
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Investigational Site Number 036001 - Nundah
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2050 - Camperdown
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2010 - Darlinghurst
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3199 - Frankston
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6150 - Murdoch
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4012 - Nundah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective:
To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597
administered subcutaneously during 52 weeks on lung function of participants with Idiopathic
Pulmonary Fibrosis (IPF).
Secondary Objectives:
To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF
disease progression.
To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in
participants with IPF.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02345070
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02345070
Download to PDF