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

• Status: Completed
• Trial end date: 2017-08-14
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria :

• Adult male or female participants.

• Documented diagnosis of IPF according to the current 2011 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 less than or equal to 40 years.

• IPF disease diagnosis greater than 5 years.

• Forced vital capacity (FVC) less than (<) 40 percent (%) 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 hours 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 for lung transplantation within the next 6 months (on an active list).

• History of vasculitis or connective tissue disorders.

• Known human immunodeficiency virus or chronic viral hepatitis.

• Participants 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 was longer), or within 12 weeks for stem cell therapy.

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