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

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT02345070

Run by

Sanofi

People needed

327

Starts

2015-05-01

Expected to finish

2017-08-14

Last updated by the study team

2022-03-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840020 — Jacksonville, Florida, United States
• Investigational Site Number 840022 — Loxahatchee Groves, Florida, United States
• Investigational Site Number 840017 — Atlanta, Georgia, United States
• Investigational Site Number 840008 — Decatur, Georgia, United States
• Investigational Site Number 840010 — Louisville, Kentucky, United States
• Investigational Site Number 840009 — Minneapolis, Minnesota, United States
• Investigational Site Number 840006 — Rochester, Minnesota, United States
• Investigational Site Number 840026 — Chesterfield, Missouri, United States
• Investigational Site Number 840001 — Lebanon, New Hampshire, United States
• Investigational Site Number 840002 — Summit, New Jersey, United States
• Investigational Site Number 840015 — Jamaica, New York, United States
• Investigational Site Number 840023 — Mineola, New York, United States
• Investigational Site Number 840012 — New York, New York, United States
• Investigational Site Number 840013 — Stony Brook, New York, United States
• Investigational Site Number 840014 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840011 — Dallas, Texas, United States
• Investigational Site Number 840024 — Everett, Washington, United States
• Investigational Site Number 032009 — Caba, Argentina
• Investigational Site Number 032005 — Caba, Argentina
• Investigational Site Number 032001 — La Plata, Argentina
• Investigational Site Number 032004 — Mendoza, Argentina
• Investigational Site Number 032002 — San Miguel de Tucumán, Argentina
• Investigational Site Number 032007 — Vicente López, Argentina
• Investigational Site Number 036005 — Camperdown, Australia
• Investigational Site Number 840003 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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