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Trial record 1 of 1 for:    nct02345070
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Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (ESTAIR)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: January 19, 2015
Last updated: July 6, 2016
Last verified: July 2016

Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: SAR156597
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change from baseline in percent predicted FVC at 52 weeks [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Proportion of patients with disease progression [ Time Frame: 1 year ]
  • Number of deaths (all causes) [ Time Frame: 1 year ]

Estimated Enrollment: 300
Study Start Date: May 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR156597 dose 1
subcutaneous injection once every week
Drug: SAR156597
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: SAR156597 dose 2
subcutaneous injection once every two weeks
Drug: SAR156597
Pharmaceutical form:solution Route of administration: subcutaneous
Placebo Comparator: placebo
subcutaneous injection once every week
Drug: placebo
Pharmaceutical form:solution Route of administration: subcutaneous

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

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

Inclusion criteria :

  • Adult male or female patients.
  • Documented diagnosis of IPF according to the current 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 ≤40 years.
  • IPF disease diagnosis >5 years.
  • Forced vital capacity (FVC) <40% 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 hrs 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 to be listed for lung transplantation within the next 6 months (on an active list).
  • History of vasculitis or connective tissue disorders.
  • Known human immunodeficiency virus (HIV) or chronic viral hepatitis.
  • Patients 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 is longer), or within 12 weeks for stem cell therapy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Please refer to this study by its identifier: NCT02345070

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Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT02345070     History of Changes
Other Study ID Numbers: DRI11772
2014-003933-24 ( EudraCT Number )
U1111-1154-6083 ( Other Identifier: UTN )
Study First Received: January 19, 2015
Last Updated: July 6, 2016

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial processed this record on May 23, 2017