Working… Menu

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

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. Identifier: NCT01529853
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : February 15, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: SAR156597 Drug: Placebo (for SAR156597) Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: SAR156597 dose 1
SAR156597 dose 1, subcutaneous injection once every week
Drug: SAR156597

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: SAR156597 dose 2
SAR156597 dose 2, subcutaneous injection once every week
Drug: SAR156597

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: SAR156597 dose 3
SAR156597 dose 3, subcutaneous injection once every week
Drug: SAR156597

Pharmaceutical form: solution

Route of administration: subcutaneous

Placebo Comparator: Placebo
Placebo (for SAR156597), subcutaneous injection once every week
Drug: Placebo (for SAR156597)

Pharmaceutical form: solution

Route of administration: subcutaneous

Primary Outcome Measures :
  1. Safety/tolerability: Number of participants with Adverse events [ Time Frame: from first dose of study drug up to Week 18 ]

Secondary Outcome Measures :
  1. Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC) [ Time Frame: from baseline to week 6 ]
  2. Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco) [ Time Frame: from baseline to week 6 ]
  3. Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ) [ Time Frame: from baseline to week 6 ]
  4. Pharmacodynamic: Change in plasma levels of biomarkers [ Time Frame: from baseline to week 18 ]
  5. Pharmacokinetic: SAR156597 plasma concentration [ Time Frame: from baseline to week 18 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01529853

Layout table for location information
United States, California
Investigational Site Number 840008
Sacramento, California, United States, 95817
United States, Florida
Investigational Site Number 840009
Jacksonville, Florida, United States, 32209
Investigational Site Number 840011
Jacksonville, Florida, United States, 32216
United States, Illinois
Investigational Site Number 840006
Chicago, Illinois, United States, 60637
Investigational Site Number 840004
Joliet, Illinois, United States, 60435
Investigational Site Number 840005
Maywood, Illinois, United States, 60153
United States, Kansas
Investigational Site Number 840002
Wichita, Kansas, United States, 67208
United States, Minnesota
Investigational Site Number 840003
Minneapolis, Minnesota, United States, 55455
United States, New York
Investigational Site Number 840013
New York, New York, United States, 10021
United States, Ohio
Investigational Site Number 840014
Cincinnati, Ohio, United States, 45267-0542
United States, South Carolina
Investigational Site Number 840010
Charleston, South Carolina, United States, 29406
Investigational Site Number 124003
Edmonton, Canada, T6G 2B7
Investigational Site Number 124001
Hamilton, Canada, L8N 4A6
Investigational Site Number 124002
Vancouver, Canada, V5Z 1M9
Investigational Site Number 152003
Santiago, Chile, 750-0691
Investigational Site Number 152001
Santiago, Chile, 7500710
Investigational Site Number 152002
Santiago, Chile, 8380456
Investigational Site Number 484003
Mexico City, Mexico, 40766
Investigational Site Number 484002
Monterrey, Mexico, 64460
Investigational Site Number 724001
Barcelona, Spain, 08036
Investigational Site Number 724002
Barcelona, Spain, 08907
Sponsors and Collaborators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Sanofi Identifier: NCT01529853     History of Changes
Other Study ID Numbers: TDR11326
2011-005481-37 ( EudraCT Number )
U1111-1124-1425 ( Other Identifier: UTN )
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial