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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02345070
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: SAR156597 Drug: placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : August 14, 2017


Arm Intervention/treatment
Placebo Comparator: Placebo qw
Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
Drug: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

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.
Drug: SAR156597
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Drug: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Experimental: SAR156597 200 mg qw
Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Drug: SAR156597
Pharmaceutical form: solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  1. Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52 [ Time Frame: Baseline, 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 :
  1. Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52 [ Time Frame: From randomization to disease progression (up to 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.

  2. Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52 [ Time Frame: From randomization up to 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345070


Locations
Hide Hide 101 study locations
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United States, Arizona
Investigational Site Number 840003
Phoenix, Arizona, United States, 85006
United States, Florida
Investigational Site Number 840020
Jacksonville, Florida, United States, 32209
Investigational Site Number 840022
Loxahatchee Groves, Florida, United States, 33470
United States, Georgia
Investigational Site Number 840017
Atlanta, Georgia, United States, 30322
Investigational Site Number 840008
Decatur, Georgia, United States, 30033
United States, Kentucky
Investigational Site Number 840010
Louisville, Kentucky, United States, 40218
United States, Minnesota
Investigational Site Number 840009
Minneapolis, Minnesota, United States, 55455
Investigational Site Number 840006
Rochester, Minnesota, United States, 55905
United States, Missouri
Investigational Site Number 840026
Chesterfield, Missouri, United States, 63017
United States, New Hampshire
Investigational Site Number 840001
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Investigational Site Number 840002
Summit, New Jersey, United States, 07901
United States, New York
Investigational Site Number 840015
Jamaica, New York, United States, 11435
Investigational Site Number 840023
Mineola, New York, United States, 11501
Investigational Site Number 840012
New York, New York, United States, 10016
Investigational Site Number 840013
Stony Brook, New York, United States, 11794-8121
United States, Pennsylvania
Investigational Site Number 840014
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Investigational Site Number 840011
Dallas, Texas, United States, 75390
United States, Washington
Investigational Site Number 840024
Everett, Washington, United States, 98208
Argentina
Investigational Site Number 032009
Caba, Argentina, C1414AIF
Investigational Site Number 032005
Caba, Argentina, C1425FVH
Investigational Site Number 032001
La Plata, Argentina, B1900DXM
Investigational Site Number 032004
Mendoza, Argentina, 5500
Investigational Site Number 032002
San Miguel De Tucumán, Argentina, T4000IAR
Investigational Site Number 032007
Vicente Lopez, Argentina, 1602
Australia
Investigational Site Number 036005
Camperdown, Australia, 2050
Investigational Site Number 036004
Darlinghurst, Australia, 2010
Investigational Site Number 036002
Frankston, Australia, 3199
Investigational Site Number 036003
Murdoch, Australia, 6150
Investigational Site Number 036001
Nundah, Australia, 4012
Canada
Investigational Site Number 124003
Toronto, Canada, M5G 2N2
Investigational Site Number 124002
Vancouver, Canada, V5Z 1M9
Chile
Investigational Site Number 152003
Quillota, Chile, 2260877
Investigational Site Number 152001
Santiago, Chile, 750-0691
Investigational Site Number 152004
Santiago, Chile, 7500698
Investigational Site Number 152006
Santiago, Chile, 8380456
Investigational Site Number 152002
Talca, Chile, 3460001
Investigational Site Number 152007
Viña Del Mar, Chile
Colombia
Investigational Site Number 170004
Armenia, Colombia, 630004
Investigational Site Number 170001
Bogota, Colombia, 110121
Investigational Site Number 170005
Cali, Colombia
Czechia
Investigational Site Number 203002
Hradec Kralove, Czechia, 50005
Investigational Site Number 203004
Olomouc, Czechia, 77900
Investigational Site Number 203003
Praha 2, Czechia, 12808
Investigational Site Number 203001
Praha 4, Czechia, 14059
Denmark
Investigational Site Number 208002
Aarhus C, Denmark, 8000
Investigational Site Number 208001
Hellerup, Denmark, 2900
France
Investigational Site Number 250007
Bobigny, France
Investigational Site Number 250002
Lille Cedex, France, 59037
Investigational Site Number 250001
Lyon, France, 69394
Investigational Site Number 250009
Marseille, France, 13015
Investigational Site Number 250005
Montpellier, France, 34295
Investigational Site Number 250004
Nice, France, 6002
Investigational Site Number 250006
Paris, France, 75018
Investigational Site Number 250008
Toulouse, France, 31059
Investigational Site Number 250003
Tours, France
Germany
Investigational Site Number 276003
Coswig, Germany, 01640
Investigational Site Number 276002
Donaustauf, Germany, 93093
Investigational Site Number 276004
Gießen, Germany, 35392
Investigational Site Number 276005
Hannover, Germany, 30625
Investigational Site Number 276001
Heidelberg, Germany, 69126
Greece
Investigational Site Number 300001
Heraklion, Greece, 71110
Israel
Investigational Site Number 376001
Haifa, Israel, 34362
Investigational Site Number 376004
Kfar Saba, Israel, 44281
Investigational Site Number 376002
Petah-Tikva, Israel, 49100
Investigational Site Number 376005
Rehovot, Israel, 76100
Investigational Site Number 376003
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 380003
Catania, Italy, 95123
Investigational Site Number 380001
Forlì, Italy, 47121
Investigational Site Number 380005
Milano, Italy, 20123
Investigational Site Number 380002
Orbassano, Italy, 10043
Investigational Site Number 380006
Pisa, Italy, 56124
Investigational Site Number 380004
Siena, Italy, 53100
Korea, Republic of
Investigational Site Number 410005
Bucheon-Si, Korea, Republic of, 14584
Investigational Site Number 410001
Incheon, Korea, Republic of, 21565
Investigational Site Number 410006
Seongnam, Korea, Republic of, 463-707
Investigational Site Number 410002
Seoul, Korea, Republic of, 02841
Investigational Site Number 410003
Seoul, Korea, Republic of, 110-744
Investigational Site Number 410004
Seoul, Korea, Republic of
Mexico
Investigational Site Number 484002
Mexico City, Mexico, 14050
Investigational Site Number 484001
Monterrey, Mexico, 64460
Investigational Site Number 484005
Monterrey, Mexico, 66465
Investigational Site Number 484003
San Juan Del Rio, Mexico, 76800
Portugal
Investigational Site Number 620003
Porto, Portugal, 4200-319
Investigational Site Number 620004
Vila Nova De Gaia, Portugal, 4400
Spain
Investigational Site Number 724003
Barcelona, Spain, 08035
Investigational Site Number 724002
Barcelona, Spain, 08036
Investigational Site Number 724001
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724004
Lugo, Spain, 27003
Investigational Site Number 724006
Majadahonda, Spain, 28222
Investigational Site Number 724005
Palma De Mallorca, Spain, 07120
Investigational Site Number 724007
Sabadell, Spain, 08208
Turkey
Investigational Site Number 792005
Ankara, Turkey, 06620
Investigational Site Number 792006
Istanbul, Turkey, 34098
Investigational Site Number 792001
Istanbul, Turkey, 34111
Investigational Site Number 792004
Istanbul, Turkey, 34390
Investigational Site Number 792003
Istanbul, Turkey, 34844
Investigational Site Number 792002
Izmir, Turkey, 35100
United Kingdom
Investigational Site Number 826002
Cambridge, United Kingdom, CB23 3RE
Investigational Site Number 826003
Exeter, United Kingdom, EX2 5DW
Investigational Site Number 826004
Leicester, United Kingdom, LE3 9QP
Investigational Site Number 826001
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
  Study Documents (Full-Text)

Documents provided by Sanofi:
Study Protocol  [PDF] July 21, 2015
Statistical Analysis Plan  [PDF] June 16, 2017

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02345070    
Other Study ID Numbers: DRI11772
2014-003933-24 ( EudraCT Number )
U1111-1154-6083 ( Other Identifier: UTN )
First Posted: January 26, 2015    Key Record Dates
Results First Posted: May 26, 2020
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to participant 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. Participant 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases