Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: SAR156597; placebo
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 327.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility 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.