Estudio de fase IIa, multicéntrico, aleatorizado, controlado con placebo y doble ciego, para evaluar la eficacia, seguridad y farmacocinética de MTPS9579A en pacientes con asma que requieren corticosteroides inhalados y un segundo controlador

CompletadoFase 2ClinicalTrials.gov

ID: NCT04092582Tipo: INTERVENTIONALInicio: 31 de oct de 2019Fin estimado: 19 de may de 2022

Resumen

Este es un estudio de fase IIa, aleatorizado, controlado con placebo, doble ciego, multicéntrico, de dos brazos, para evaluar la eficacia, seguridad y farmacocinética de MTPS9579A como terapia complementaria en pacientes con asma moderada a grave no controlada que reciben terapia diaria con corticosteroides inhalados (CI) y al menos uno de los siguientes medicamentos controladores adicionales: agonista beta de acción prolongada (LABA), modulador de leucotrienos (modificador de leucotrienos [LTM] o antagonista del receptor de leucotrienos [LTRA]), antagonista muscarínico de acción prolongada (LAMA) o preparación de teofilina de acción prolongada.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Documented physician-diagnosed asthma for at least 12 months prior to screening
Treatment with asthma controller therapy (daily ICS \[fluticasone propionate or equivalent\] and at least one additional controller therapy \[LABA, LAMA, LTM/LTRA\]) for \>= 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the study
Documented history of \>= 2 asthma exacerbation within the 12 months prior to screening while on daily ICS maintenance therapy
For women of childbearing potential: agreement to remain abstinent or use contraception For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

Criterios de exclusión

History or evidence of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation associated with panic attacks, or other mimics of asthma
History or evidence of significant respiratory disease other than asthma, including occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome, bronchiolitis, interstitial lung disease, or COPD
Current smoker, electronic cigarette (e-cigarette) user, former smoker with smoking history of \> 10 pack-years, former e-cigarette user with an e-cigarette history of at least daily use for \>=10 years, or unwilling to abstain from smoking and/or e-cigarette use from the time of consent through the completion of the study
History or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, precludes the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study
Active malignancy or history of malignancy within 5 years of screening, except for appropriately treated non-melanoma skin carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or Stage I uterine cancer
Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of MTPS9579A
Positive for TB at screening

Intervenciones

drug

MTPS9579A

MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.

drug

Placebo

Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46.

Ubicaciones

Fundacion Cidea

Buenos Aires, Argentina

Centro Médico Dra. Cristina de Salvo

Buenos Aires, Argentina

CARE - Centro de Alergia y Enfermedades Respiratorias

CABA, Argentina

Centro Respiratorio Quilmes

Quilmes, Argentina

Patrocinadores

PrincipalGenentech, Inc.

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