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To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SAR156597
Placebo (for SAR156597)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Adult (aged >18 years) 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/ALTA) guidelines

Exclusion criteria:

  • Forced vital capacity (FVC) <50% of predicted value Carbon monoxide diffusing lung capacity (DLCO) (corrected for hemoglobin) <35% predicted value
  • Oxygen saturation <90% by pulse oximetry while breathing ambient air at rest (sitting position for 10 min)
  • Known diagnosis of significant respiratory disorders other than IPF
  • Active vasculopathy or use of vasoactive drugs
  • Known HIV or chronic viral hepatitis
  • Patients with active tuberculosis or latent tuberculosis infection
  • Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical (other than IPF) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator
  • Clinically significant abnormal ECG at screening
  • Clinically significant laboratory tests at screening
  • Current history of substance and/or alcohol abuse
  • Females who are lactating or who are pregnant.
  • Use of any registered therapy targeted to treat IPF within 4 weeks prior to screening
  • Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks prior to screening

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

Sites / Locations

  • Investigational Site Number 840008
  • Investigational Site Number 840009
  • Investigational Site Number 840011
  • Investigational Site Number 840006
  • Investigational Site Number 840004
  • Investigational Site Number 840005
  • Investigational Site Number 840002
  • Investigational Site Number 840003
  • Investigational Site Number 840013
  • Investigational Site Number 840014
  • Investigational Site Number 840010
  • Investigational Site Number 124003
  • Investigational Site Number 124001
  • Investigational Site Number 124002
  • Investigational Site Number 152003
  • Investigational Site Number 152001
  • Investigational Site Number 152002
  • Investigational Site Number 484003
  • Investigational Site Number 484002
  • Investigational Site Number 724001
  • Investigational Site Number 724002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SAR156597 dose 1

SAR156597 dose 2

SAR156597 dose 3

Placebo

Arm Description

SAR156597 dose 1, subcutaneous injection once every week

SAR156597 dose 2, subcutaneous injection once every week

SAR156597 dose 3, subcutaneous injection once every week

Placebo (for SAR156597), subcutaneous injection once every week

Outcomes

Primary Outcome Measures

Safety/tolerability: Number of participants with Adverse events

Secondary Outcome Measures

Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)
Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)
Pharmacodynamic: Change in plasma levels of biomarkers
Pharmacokinetic: SAR156597 plasma concentration

Full Information

First Posted
February 6, 2012
Last Updated
January 22, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01529853
Brief Title
To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Repeated Doses of SAR156597 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period. Secondary Objectives: To assess in adult patients with IPF: The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers. The trough plasma concentrations of SAR156597 The potential immunogenicity of SAR156597.
Detailed Description
The study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. Total study duration is up to 22 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR156597 dose 1
Arm Type
Experimental
Arm Description
SAR156597 dose 1, subcutaneous injection once every week
Arm Title
SAR156597 dose 2
Arm Type
Experimental
Arm Description
SAR156597 dose 2, subcutaneous injection once every week
Arm Title
SAR156597 dose 3
Arm Type
Experimental
Arm Description
SAR156597 dose 3, subcutaneous injection once every week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for SAR156597), subcutaneous injection once every week
Intervention Type
Drug
Intervention Name(s)
SAR156597
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo (for SAR156597)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Safety/tolerability: Number of participants with Adverse events
Time Frame
from first dose of study drug up to Week 18
Secondary Outcome Measure Information:
Title
Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)
Time Frame
from baseline to week 6
Title
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)
Time Frame
from baseline to week 6
Title
Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)
Time Frame
from baseline to week 6
Title
Pharmacodynamic: Change in plasma levels of biomarkers
Time Frame
from baseline to week 18
Title
Pharmacokinetic: SAR156597 plasma concentration
Time Frame
from baseline to week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Adult (aged >18 years) 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/ALTA) guidelines Exclusion criteria: Forced vital capacity (FVC) <50% of predicted value Carbon monoxide diffusing lung capacity (DLCO) (corrected for hemoglobin) <35% predicted value Oxygen saturation <90% by pulse oximetry while breathing ambient air at rest (sitting position for 10 min) Known diagnosis of significant respiratory disorders other than IPF Active vasculopathy or use of vasoactive drugs Known HIV or chronic viral hepatitis Patients with active tuberculosis or latent tuberculosis infection Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical (other than IPF) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator Clinically significant abnormal ECG at screening Clinically significant laboratory tests at screening Current history of substance and/or alcohol abuse Females who are lactating or who are pregnant. Use of any registered therapy targeted to treat IPF within 4 weeks prior to screening Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks prior to screening The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840008
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Investigational Site Number 840009
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Investigational Site Number 840011
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 840006
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Investigational Site Number 840004
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Investigational Site Number 840005
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Investigational Site Number 840002
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Investigational Site Number 840003
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Investigational Site Number 840013
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Investigational Site Number 840014
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0542
Country
United States
Facility Name
Investigational Site Number 840010
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigational Site Number 124003
City
Edmonton
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Investigational Site Number 124001
City
Hamilton
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Investigational Site Number 124002
City
Vancouver
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Investigational Site Number 152003
City
Santiago
ZIP/Postal Code
750-0691
Country
Chile
Facility Name
Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Investigational Site Number 152002
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Investigational Site Number 484003
City
Mexico City
ZIP/Postal Code
40766
Country
Mexico
Facility Name
Investigational Site Number 484002
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 724001
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

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