Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

Overview

About this study

Primary Objective: To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with Idiopathic Pulmonary Fibrosis (IPF). Secondary Objectives: To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression. To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult 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/ALAT) guidelines.
  • Signed written informed consent.

Exclusion Criteria:

  • Age ≤40 years.
  • IPF disease diagnosis >5 years.
  • Forced vital capacity (FVC) <40% of predicted value.
  • Carbon monoxide diffusing lung capacity (DLco) corrected for hemoglobin <30% of predicted value.
  • Severe chronic obstructive bronchitis as characterized by forced expiratory volume in 1 second /forced vital capacity (FEV1/FVC) <0.70.
  • Need for 24 hrs of oxygen therapy or oxygen saturation <88% after 10 minutes breathing ambient air at rest.
  • Known diagnosis of significant respiratory disorders other than IPF.
  • Pulmonary artery hypertension requiring a specific treatment.
  • Currently listed and/or anticipated to be listed for lung transplantation within the next 6 months (on an active list).
  • History of vasculitis or connective tissue disorders.
  • Known human immunodeficiency virus (HIV) or chronic viral hepatitis.
  • Patients with active tuberculosis or incompletely treated latent tuberculosis infection.
  • Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to screening.
  • Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24 weeks for rituximab and 24 months for alefacept).
  • Use of any investigational drug within 1 month of screening, or 5 half-lives, if known ( whichever is longer), or within 12 weeks for stem cell therapy.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

James Utz, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20151022

Mayo Clinic Footer