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

• ClinicalTrials.gov Identifier: NCT02345070
• Recruitment Status: Completed
• First Posted: January 26, 2015
• Results First Posted: May 26, 2020
• Last Update Posted: March 24, 2022
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

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.

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

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Caba, Argentina, C1425FVH

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La Plata, Argentina, B1900DXM

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Mendoza, Argentina, 5500

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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

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Nundah, Australia, 4012

Canada

Investigational Site Number 124003

Toronto, Canada, M5G 2N2

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Vancouver, Canada, V5Z 1M9

Chile

Investigational Site Number 152003

Quillota, Chile, 2260877

Investigational Site Number 152001

Santiago, Chile, 750-0691

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Santiago, Chile, 7500698

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Santiago, Chile, 8380456

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Talca, Chile, 3460001

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Viña Del Mar, Chile

Colombia

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Armenia, Colombia, 630004

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Bogota, Colombia, 110121

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Cali, Colombia

Czechia

Investigational Site Number 203002

Hradec Kralove, Czechia, 50005

Investigational Site Number 203004

Olomouc, Czechia, 77900

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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

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Marseille, France, 13015

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Montpellier, France, 34295

Investigational Site Number 250004

Nice, France, 6002

Investigational Site Number 250006

Paris, France, 75018

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Toulouse, France, 31059

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Tours, France

Germany

Investigational Site Number 276003

Coswig, Germany, 01640

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Donaustauf, Germany, 93093

Investigational Site Number 276004

Gießen, Germany, 35392

Investigational Site Number 276005

Hannover, Germany, 30625

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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

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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

• 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

More Information

• 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
• Results First Posted: May 26, 2020
• Last Update Posted: March 24, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases