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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02345070




Registration number
NCT02345070
Ethics application status
Date submitted
19/01/2015
Date registered
26/01/2015
Date last updated
15/06/2018

Titles & IDs
Public title
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
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
Secondary ID [1] 0 0
2014-003933-24
Secondary ID [2] 0 0
DRI11772
Universal Trial Number (UTN)
Trial acronym
ESTAIR
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 - SAR156597
Treatment: Drugs - placebo

Experimental: SAR156597 dose 1 - subcutaneous injection once every week

Experimental: SAR156597 dose 2 - subcutaneous injection once every two weeks

Placebo Comparator: placebo - subcutaneous injection once every week


Treatment: Drugs: SAR156597
Pharmaceutical form:solution Route of administration: subcutaneous

Treatment: Drugs: placebo
Pharmaceutical form:solution Route of administration: subcutaneous

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in percent predicted Forced Vital Capacity (FVC)
Timepoint [1] 0 0
Baseline to week 52
Secondary outcome [1] 0 0
Proportion of patients with disease progression
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Number of deaths (all causes)
Timepoint [2] 0 0
Week 52

Eligibility
Key inclusion criteria
Inclusion criteria :

- Adult male or female patients.

- Documented diagnosis of IPF according to the current American Thoracic
Society/European Respiratory Society/Japanese Respiratory Society/ American Latin
Thoracic Association (ATS/ERS/JRS/ALAT) guidelines.

- Signed written informed consent.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Age =40 years.

- IPF disease diagnosis >5 years.

- Forced vital capacity (FVC) <40% 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 hrs 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 to be listed for lung transplantation within the
next 6 months (on an active list).

- History of vasculitis or connective tissue disorders.

- Known human immunodeficiency virus (HIV) or chronic viral hepatitis.

- Patients 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 is longer), or within 12 weeks for stem cell therapy.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036005 - Camperdown
Recruitment hospital [2] 0 0
Investigational Site Number 036004 - Darlinghurst
Recruitment hospital [3] 0 0
Investigational Site Number 036002 - Frankston
Recruitment hospital [4] 0 0
Investigational Site Number 036003 - Murdoch
Recruitment hospital [5] 0 0
Investigational Site Number 036001 - Nundah
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
4012 - Nundah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
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Missouri
Country [7] 0 0
United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
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Washington
Country [13] 0 0
Argentina
State/province [13] 0 0
Caba
Country [14] 0 0
Argentina
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La Plata
Country [15] 0 0
Argentina
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Mendoza
Country [16] 0 0
Argentina
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San Miguel De Tucumán
Country [17] 0 0
Argentina
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Vicente Lopez
Country [18] 0 0
Canada
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Toronto
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Canada
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Vancouver
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Chile
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Quillota
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Chile
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Santiago
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Chile
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Talca
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Chile
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Viña Del Mar
Country [24] 0 0
Colombia
State/province [24] 0 0
Armenia
Country [25] 0 0
Colombia
State/province [25] 0 0
Bogota
Country [26] 0 0
Colombia
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Cali
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Praha 2
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Czechia
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Praha 4
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Denmark
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Aarhus C
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Denmark
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Hellerup
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France
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Bobigny
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France
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Lille Cedex
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France
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Lyon
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France
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Marseille
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Montpellier
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Nice
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Paris
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Toulouse
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France
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Tours
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Germany
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Coswig
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Germany
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Donaustauf
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Germany
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Gießen
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Germany
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Hannover
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Germany
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Heidelberg
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Greece
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Heraklion
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Petah-Tikva
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Israel
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Rehovot
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Israel
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Tel Hashomer
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Italy
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Catania
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Italy
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Forlì
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Milano
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Italy
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Orbassano
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Italy
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Pisa
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Italy
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Siena
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Korea, Republic of
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Bucheon-Si
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Incheon
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Seongnam
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Seoul
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Mexico City
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Mexico
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Monterrey
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San Juan Del Rio
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Portugal
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Porto
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Vila Nova De Gaia
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Spain
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Barcelona
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Spain
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Hospitalet De Llobregat
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Spain
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Lugo
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Majadahonda
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Spain
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Palma De Mallorca
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Spain
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Sabadell
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Cambridge
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Exeter
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Leicester
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597
administered subcutaneously during 52 weeks on lung function of patients with Idiopathic
Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease
progression.

To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with
IPF.
Trial website
https://clinicaltrials.gov/show/NCT02345070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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

Summary results
Other publications