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Trial details imported from ClinicalTrials.gov

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

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
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) at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52
Timepoint [1] 0 0
From randomization to disease progression (up to Week 52)
Secondary outcome [2] 0 0
Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52
Timepoint [2] 0 0
From randomization up to Week 52

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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/08/2017
Sample size
Target
Accrual to date
Final
327
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
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United States of America
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Kentucky
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United States of America
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Minnesota
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United States of America
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Missouri
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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
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Texas
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United States of America
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Washington
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Argentina
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Caba
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Argentina
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La Plata
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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
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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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France
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Montpellier
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France
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Nice
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France
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Paris
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France
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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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Italy
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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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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Mexico
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Mexico City
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Mexico
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Monterrey
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Mexico
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San Juan Del Rio
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Portugal
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Porto
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Portugal
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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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Spain
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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
State/province [77] 0 0
Cambridge
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United Kingdom
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Exeter
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United Kingdom
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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/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.
Trial website
https://clinicaltrials.gov/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02345070