Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

ID: NCT02345070
Status: Completed
Phase: Phase 2
Start Date: May 01, 2015
First Submitted: January 19, 2015
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: Argentina, Australia, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Korea, Republic of, Mexico, Portugal, Spain, Turkey, United Kingdom, United States
Conditions: Idiopathic Pulmonary Fibrosis
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Study Description

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.

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).
Condition or disease Intervention/treatment Phase

Idiopathic Pulmonary Fibrosis

Drug: SAR156597
Other Names
Drug: placebo
Other Names
Phase 2

Tracking Information

First Submitted DateJanuary 19, 2015
Last Update Posted DateFebruary 22, 2018
Start DateMay 01, 2015
Actual Completion DateAugust 14, 2017
Primary Completion DateMay 22, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Proportion of patients with disease progression [Time Frame: 1 year]

  • Number of deaths (all causes) [Time Frame: 1 year]

Original Secondary Outcome Measures

Not Available

Study Design

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

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 TypeInterventional
Study PhasePhase 2
Estimated Enrollment
327
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Idiopathic Pulmonary Fibrosis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: SAR156597

Pharmaceutical form:solution Route of administration: subcutaneous

Other Names
Drug: placebo

Pharmaceutical form:solution Route of administration: subcutaneous

Other Names
Study Groups/Cohorts
SAR156597 dose 1
subcutaneous injection once every week

SAR156597 dose 2
subcutaneous injection once every two weeks

placebo
subcutaneous injection once every week

Study Arms
Placebo Comparator placebo
subcutaneous injection once every week
Drug : placebo
Pharmaceutical form:solution Route of administration: subcutaneous

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

Arm Intervention/Treatment
Placebo Comparator placebo
subcutaneous injection once every week
Drug : placebo
Experimental SAR156597 dose 1
subcutaneous injection once every week
Drug : SAR156597
Experimental SAR156597 dose 2
subcutaneous injection once every two weeks
Drug : SAR156597

Recruitment Information

Recruitment Status:Completed
Enrollment327
Completion DateAugust 14, 2017
Eligibility 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.
GenderAll
Age40 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Argentina
Australia
Canada
Chile
Colombia
Czechia
Denmark
France
Germany
Greece
Israel
Italy
Korea, Republic of
Mexico
Portugal
Spain
Turkey
United Kingdom
United States
Czech Republic

Administrative Information

NCT Number:NCT02345070
Other Study ID Numbers
DRI11772
2014-003933-24
U1111-1154-6083
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi