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Sponsor: Sanofi
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: SAR156597, placebo
Countries: United States, Argentina, Australia, Canada, Chile, Colombia, Czechia, Denmark
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.
Sex: ALL
Age: 40 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Loxahatchee Groves, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Louisville, Kentucky, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Chesterfield, Missouri, United States
- Lebanon, New Hampshire, United States
- Summit, New Jersey, United States
- Jamaica, New York, United States
- Mineola, New York, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Everett, Washington, United States
- Caba, Argentina
- Caba, Argentina
- La Plata, Argentina
- Mendoza, Argentina
- San Miguel de Tucumán, Argentina
- Vicente López, Argentina
- Camperdown, Australia
- Darlinghurst, Australia
- Frankston, Australia
- Murdoch, Australia
- Nundah, Australia
- Toronto, Canada
- + 71 more on CT.gov