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

March 15, 2022 updated by: Sanofi

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Drug: SAR156597
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to disease progression (up to Week 52)
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.
From randomization up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

August 14, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI11772
  • 2014-003933-24 (EudraCT Number)
  • U1111-1154-6083 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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