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

Phase 1

• Conditions: Idiopathic pulmonary fibrosis; MedDRA version: 18.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-003933-24-DK
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-20
• Last Update Posted: 6 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified