search
Back to results

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR156597
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Investigational Site Number 840003
  • Investigational Site Number 840020
  • Investigational Site Number 840022
  • Investigational Site Number 840017
  • Investigational Site Number 840008
  • Investigational Site Number 840010
  • Investigational Site Number 840009
  • Investigational Site Number 840006
  • Investigational Site Number 840026
  • Investigational Site Number 840001
  • Investigational Site Number 840002
  • Investigational Site Number 840015
  • Investigational Site Number 840023
  • Investigational Site Number 840012
  • Investigational Site Number 840013
  • Investigational Site Number 840014
  • Investigational Site Number 840011
  • Investigational Site Number 840024
  • Investigational Site Number 032009
  • Investigational Site Number 032005
  • Investigational Site Number 032001
  • Investigational Site Number 032004
  • Investigational Site Number 032002
  • Investigational Site Number 032007
  • Investigational Site Number 036005
  • Investigational Site Number 036004
  • Investigational Site Number 036002
  • Investigational Site Number 036003
  • Investigational Site Number 036001
  • Investigational Site Number 124003
  • Investigational Site Number 124002
  • Investigational Site Number 152003
  • Investigational Site Number 152001
  • Investigational Site Number 152004
  • Investigational Site Number 152006
  • Investigational Site Number 152002
  • Investigational Site Number 152007
  • Investigational Site Number 170004
  • Investigational Site Number 170001
  • Investigational Site Number 170005
  • Investigational Site Number 203002
  • Investigational Site Number 203004
  • Investigational Site Number 203003
  • Investigational Site Number 203001
  • Investigational Site Number 208002
  • Investigational Site Number 208001
  • Investigational Site Number 250007
  • Investigational Site Number 250002
  • Investigational Site Number 250001
  • Investigational Site Number 250009
  • Investigational Site Number 250005
  • Investigational Site Number 250004
  • Investigational Site Number 250006
  • Investigational Site Number 250008
  • Investigational Site Number 250003
  • Investigational Site Number 276003
  • Investigational Site Number 276002
  • Investigational Site Number 276004
  • Investigational Site Number 276005
  • Investigational Site Number 276001
  • Investigational Site Number 300001
  • Investigational Site Number 376001
  • Investigational Site Number 376004
  • Investigational Site Number 376002
  • Investigational Site Number 376005
  • Investigational Site Number 376003
  • Investigational Site Number 380003
  • Investigational Site Number 380001
  • Investigational Site Number 380005
  • Investigational Site Number 380002
  • Investigational Site Number 380006
  • Investigational Site Number 380004
  • Investigational Site Number 410005
  • Investigational Site Number 410001
  • Investigational Site Number 410006
  • Investigational Site Number 410002
  • Investigational Site Number 410003
  • Investigational Site Number 410004
  • Investigational Site Number 484002
  • Investigational Site Number 484001
  • Investigational Site Number 484005
  • Investigational Site Number 484003
  • Investigational Site Number 620003
  • Investigational Site Number 620004
  • Investigational Site Number 724003
  • Investigational Site Number 724002
  • Investigational Site Number 724001
  • Investigational Site Number 724004
  • Investigational Site Number 724006
  • Investigational Site Number 724005
  • Investigational Site Number 724007
  • Investigational Site Number 792005
  • Investigational Site Number 792006
  • Investigational Site Number 792001
  • Investigational Site Number 792004
  • Investigational Site Number 792003
  • Investigational Site Number 792002
  • Investigational Site Number 826002
  • Investigational Site Number 826003
  • Investigational Site Number 826004
  • Investigational Site Number 826001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo qw

SAR156597 200 mg q2w

SAR156597 200 mg qw

Arm Description

Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.

Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.

Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 19, 2015
Last Updated
March 15, 2022
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT02345070
Brief Title
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
Acronym
ESTAIR
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
August 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo qw
Arm Type
Placebo Comparator
Arm Description
Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
Arm Title
SAR156597 200 mg q2w
Arm Type
Experimental
Arm Description
Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
Arm Title
SAR156597 200 mg qw
Arm Type
Experimental
Arm Description
Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
SAR156597
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
Description
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.
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52
Description
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.
Time Frame
From randomization to disease progression (up to Week 52)
Title
Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52
Description
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.
Time Frame
From randomization up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840003
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Investigational Site Number 840020
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Investigational Site Number 840022
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Investigational Site Number 840017
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Site Number 840008
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Investigational Site Number 840010
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
Investigational Site Number 840009
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Investigational Site Number 840006
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Investigational Site Number 840026
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Investigational Site Number 840001
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Investigational Site Number 840002
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Investigational Site Number 840015
City
Jamaica
State/Province
New York
ZIP/Postal Code
11435
Country
United States
Facility Name
Investigational Site Number 840023
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Investigational Site Number 840012
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Investigational Site Number 840013
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States
Facility Name
Investigational Site Number 840014
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Site Number 840011
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Investigational Site Number 840024
City
Everett
State/Province
Washington
ZIP/Postal Code
98208
Country
United States
Facility Name
Investigational Site Number 032009
City
Caba
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Investigational Site Number 032005
City
Caba
ZIP/Postal Code
C1425FVH
Country
Argentina
Facility Name
Investigational Site Number 032001
City
La Plata
ZIP/Postal Code
B1900DXM
Country
Argentina
Facility Name
Investigational Site Number 032004
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Investigational Site Number 032002
City
San Miguel De Tucumán
ZIP/Postal Code
T4000IAR
Country
Argentina
Facility Name
Investigational Site Number 032007
City
Vicente Lopez
ZIP/Postal Code
1602
Country
Argentina
Facility Name
Investigational Site Number 036005
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Investigational Site Number 036004
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Investigational Site Number 036002
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
Investigational Site Number 036003
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Investigational Site Number 036001
City
Nundah
ZIP/Postal Code
4012
Country
Australia
Facility Name
Investigational Site Number 124003
City
Toronto
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Investigational Site Number 124002
City
Vancouver
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Investigational Site Number 152003
City
Quillota
ZIP/Postal Code
2260877
Country
Chile
Facility Name
Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
750-0691
Country
Chile
Facility Name
Investigational Site Number 152004
City
Santiago
ZIP/Postal Code
7500698
Country
Chile
Facility Name
Investigational Site Number 152006
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Investigational Site Number 152002
City
Talca
ZIP/Postal Code
3460001
Country
Chile
Facility Name
Investigational Site Number 152007
City
Viña Del Mar
Country
Chile
Facility Name
Investigational Site Number 170004
City
Armenia
ZIP/Postal Code
630004
Country
Colombia
Facility Name
Investigational Site Number 170001
City
Bogota
ZIP/Postal Code
110121
Country
Colombia
Facility Name
Investigational Site Number 170005
City
Cali
Country
Colombia
Facility Name
Investigational Site Number 203002
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number 203004
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Investigational Site Number 203003
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number 203001
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Investigational Site Number 208002
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Investigational Site Number 208001
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Investigational Site Number 250007
City
Bobigny
Country
France
Facility Name
Investigational Site Number 250002
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250001
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Investigational Site Number 250009
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Investigational Site Number 250005
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250004
City
Nice
ZIP/Postal Code
6002
Country
France
Facility Name
Investigational Site Number 250006
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Investigational Site Number 250008
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number 250003
City
Tours
Country
France
Facility Name
Investigational Site Number 276003
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Investigational Site Number 276002
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Investigational Site Number 276004
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Investigational Site Number 276005
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Investigational Site Number 276001
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Investigational Site Number 300001
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
Investigational Site Number 376001
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Investigational Site Number 376004
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Investigational Site Number 376002
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Investigational Site Number 376005
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Investigational Site Number 376003
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number 380003
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Investigational Site Number 380001
City
Forlì
ZIP/Postal Code
47121
Country
Italy
Facility Name
Investigational Site Number 380005
City
Milano
ZIP/Postal Code
20123
Country
Italy
Facility Name
Investigational Site Number 380002
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Investigational Site Number 380006
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Investigational Site Number 380004
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Investigational Site Number 410005
City
Bucheon-Si
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Investigational Site Number 410001
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Investigational Site Number 410002
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Investigational Site Number 410003
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 410004
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 484002
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Investigational Site Number 484001
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 484005
City
Monterrey
ZIP/Postal Code
66465
Country
Mexico
Facility Name
Investigational Site Number 484003
City
San Juan Del Rio
ZIP/Postal Code
76800
Country
Mexico
Facility Name
Investigational Site Number 620003
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Investigational Site Number 620004
City
Vila Nova De Gaia
ZIP/Postal Code
4400
Country
Portugal
Facility Name
Investigational Site Number 724003
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724001
City
Hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724004
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Investigational Site Number 724006
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Investigational Site Number 724005
City
Palma De Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Investigational Site Number 724007
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number 792005
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Investigational Site Number 792006
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Investigational Site Number 792001
City
Istanbul
ZIP/Postal Code
34111
Country
Turkey
Facility Name
Investigational Site Number 792004
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Investigational Site Number 792003
City
Istanbul
ZIP/Postal Code
34844
Country
Turkey
Facility Name
Investigational Site Number 792002
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Investigational Site Number 826002
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Investigational Site Number 826003
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Investigational Site Number 826004
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Investigational Site Number 826001
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

We'll reach out to this number within 24 hrs