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

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)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: SAR156597; Drug: Placebo (for 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety/tolerability: Number of participants with Adverse events	from first dose of study drug up to Week 18

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacodynamic: Change in forced (expiratory) vital capacity (FVC)	from baseline to week 6
Pharmacodynamic: Change in carbon monoxide diffusing lung capacity (DLco)	from baseline to week 6
Pharmacodynamic: Change in Saint George Respiratory Questionnaire (SGRQ)	from baseline to week 6
Pharmacodynamic: Change in plasma levels of biomarkers	from baseline to week 18
Pharmacokinetic: SAR156597 plasma concentration	from baseline to week 18

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (ESTIMATE): February 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 15, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: TDR11326; 2011-005481-37 (EUDRACT_NUMBER); U1111-1124-1425 (OTHER: UTN)