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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01529853
First received: February 6, 2012
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: SAR156597
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety/tolerability as measured by : Adverse events/treatment-emergent adverse events; Clinical laboratory evaluations [ Time Frame: up to 6 months from first dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in forced (expiratory) vital capacity (FVC) [ Time Frame: from baseline at week 6 ] [ Designated as safety issue: No ]
  • Change in carbon monoxide diffusing lung capacity (DLco) [ Time Frame: from baseline at week 6 ] [ Designated as safety issue: No ]
  • Change in Saint George Respiratory Questionnaire (SGRQ) [ Time Frame: from baseline at week 6 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR156597 (three ascending dose cohorts)
Repeated subcutaneous dose injection of SAR156597 at 3 ascending doses
Drug: SAR156597

Pharmaceutical form:solution

Route of administration: subcutaneous

Placebo Comparator: Placebo
Repeated subcutaneous dose injection of placebo
Drug: Placebo

Pharmaceutical form:solution

Route of administration: subcutaneous


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529853

Locations
United States, California
Investigational Site Number 840008
Sacramento, California, United States, 95817
United States, Florida
Investigational Site Number 840011
Jacksonville, Florida, United States, 32216
Investigational Site Number 840009
Jacksonville, Florida, United States, 32209
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
Canada
Investigational Site Number 124003
Edmonton, Canada, T6G 2B7
Investigational Site Number 124001
Hamilton, Canada, L8N 4A6
Investigational Site Number 124002
Vancouver, Canada, V5Z 1M9
Chile
Investigational Site Number 152002
Santiago, Chile, 8380456
Investigational Site Number 152001
Santiago, Chile, 7500710
Investigational Site Number 152003
Santiago, Chile, 750-0691
Mexico
Investigational Site Number 484003
Mexico City, Mexico, 40766
Investigational Site Number 484002
Monterrey, Mexico, 64460
Spain
Investigational Site Number 724002
Barcelona, Spain, 08907
Investigational Site Number 724001
Barcelona, Spain, 08036
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01529853     History of Changes
Other Study ID Numbers: TDR11326, 2011-005481-37, U1111-1124-1425
Study First Received: February 6, 2012
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014