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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
26/05/2020

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 - 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.
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 - 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.
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 - 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.
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
Gender
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
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
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Florida
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Georgia
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Kentucky
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Minnesota
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Missouri
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New Hampshire
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New Jersey
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New York
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Pennsylvania
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Texas
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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
State/province [18] 0 0
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
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Armenia
Country [25] 0 0
Colombia
State/province [25] 0 0
Bogota
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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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Tours
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Coswig
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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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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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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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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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Lugo
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Majadahonda
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Palma De Mallorca
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Sabadell
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Turkey
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Ankara
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Istanbul
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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/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/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