Estudio de eficacia y seguridad de 52 semanas, doble cieg... | EligiMed

Estudio de eficacia y seguridad de 52 semanas, doble ciego, controlado con placebo, de grupos paralelos, de reslizumab 110 mg a dosis fija subcutánea en pacientes con asma no controlada y eosinófilos en sangre elevados

CompletadoFase 3ClinicalTrials.gov

ID: NCT02452190Tipo: INTERVENTIONALInicio: 28 de sept de 2015Fin estimado: 31 de ene de 2018

Resumen

El objetivo primario de este estudio es determinar el efecto de reslizumab (110 mg) administrado por vía subcutánea cada 4 semanas sobre las exacerbaciones clínicas del asma en adultos y adolescentes con asma y eosinófilos en sangre elevados que presentan un control inadecuado con la terapia estándar para el asma.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Written informed consent is obtained.
The participant is male or female, 12 years of age and older, with a diagnosis of asthma.
The participant has Forced Expiratory Volume in 1 Second (FEV1) reversibility according to standard American Thoracic Society (ATS) or European Respiratory Society (ERS) protocol.
The participant has required an inhaled corticosteroid.
The participant has required an additional asthma controller medication besides inhaled corticosteroids.
The participant has a history of asthma exacerbation.
The participant must be willing and able to comply with study restrictions, perform requisite procedures and remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.
Additional criteria may apply, please contact the investigator for more information

Criterios de exclusión

The participant has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures, interpretation of efficacy results, or compromise the patient's safety.
The participant has another confounding underlying lung disorder
The participant has a known hypereosinophilic syndrome.
The participant has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
The participant is a pregnant or lactating woman, or intends to become pregnant during the study. Any woman becoming pregnant during the study will be withdrawn from the study.
The participant is a current smoker or has a smoking history.
The participated in a clinical trial within 30 days or 5 half-lives of the investigational drug before screening, whichever is longer.
The participant was previously exposed to reslizumab.
The participant has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).
The participant has current or suspected drug and alcohol abuse.
The participant has an active helminthic parasitic infection or was treated for one within 6 months of screening.
The participant has a history of allergic reaction or hypersensitivity to any component of the study drug.
Additional criteria may apply, please contact the investigator for more information

Intervenciones

drug

Reslizumab

Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.

drug

Placebo

Matching Placebo

Ubicaciones

Teva Investigational Site 20040

Buenos Aires, Argentina

Teva Investigational Site 20033

Buenos Aires, Argentina

Teva Investigational Site 20035

Buenos Aires, Argentina

Teva Investigational Site 20041

Córdoba, Argentina

Teva Investigational Site 20053

Lanús, Argentina

Teva Investigational Site 20037

Mar del Plata, Argentina

Teva Investigational Site 20036

Mendoza, Argentina

Teva Investigational Site 20054

Rosario, Argentina

Teva Investigational Site 20032

Rosario, Argentina

Teva Investigational Site 20046

San Miguel de Tucumán, Argentina

Teva Investigational Site 20045

San Rafael, Argentina

Patrocinadores

PrincipalTeva Branded Pharmaceutical Products R&D, Inc.

ColaboradorPPD Development, LP

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