Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study

CompletadoFase 2ClinicalTrials.gov

ID: NCT02345070Tipo: INTERVENTIONALInicio: 1 de may de 2015Fin estimado: 14 de ago de 2017

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

SAR156597

Pharmaceutical form: solution for injection Route of administration: subcutaneous

drug

placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Ubicaciones

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

Patrocinadores

PrincipalSanofi

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