Skip to main content
OpenTrials
Completed

NCT Number: NCT01529853

To Evaluate the Effect of Different Doses of SAR156597 Given to 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site Number 124003, Edmonton, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR156597

Drug

Pharmaceutical form: solution

Route of administration: subcutaneous

Placebo (for SAR156597)

Drug

Pharmaceutical form: solution

Route of administration: subcutaneous

Primary outcomes

  1. Safety/tolerability: Number of participants with Adverse events

    Time frame: from first dose of study drug up to Week 18

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2012
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.