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

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ClinicalTrials.gov Identifier: NCT02345070
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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

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).

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
Study Start Date : May 1, 2015
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : August 14, 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Absolute change from baseline in percent predicted Forced Vital Capacity (FVC) [ Time Frame: Baseline to week 52 ]

Secondary Outcome Measures :
  1. Proportion of patients with disease progression [ Time Frame: Week 52 ]
  2. Number of deaths (all causes) [ Time Frame: Week 52 ]


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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 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.


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


  Show 101 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02345070     History of Changes
Other Study ID Numbers: DRI11772
2014-003933-24 ( EudraCT Number )
U1111-1154-6083 ( Other Identifier: UTN )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial