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

Phase 1

• Conditions: Idiopathic pulmonary fibrosis; MedDRA version: 21.1Level: 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-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-14
• Study Start: 2021-05-27
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 327

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)

Study & Design

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