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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
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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