Resumen

Este estudio aleatorizado, multicéntrico, doble ciego, controlado con placebo y de grupos paralelos evaluará la eficacia, seguridad y tolerabilidad de lebrikizumab en participantes adolescentes con asma cuya enfermedad permanece no controlada a pesar del tratamiento diario con terapia de corticosteroides inhalados (CSI) y al menos un segundo medicamento controlador. Los participantes serán aleatorizados en una razón 1:1:1 para recibir tratamiento doble ciego con lebrikizumab (dosis 'alta' o 'baja') o placebo, administrado por vía subcutánea (SC) cada 4 semanas (Q4W) durante 52 semanas, además de su terapia de tratamiento estándar. Esto será seguido de una extensión de tratamiento activo doble ciego opcional de 52 semanas. El tiempo anticipado de tratamiento en el estudio es de hasta 104 semanas. Los participantes que completen el estudio hasta la semana 104, lo interrumpan de forma prematura o decidan no participar en la extensión de tratamiento activo opcional, pasarán a un período de seguimiento de seguridad de 20 semanas.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Asthma diagnosis for greater than or equal to (\>/=) 12 months prior to Visit 1
Bronchodilator response during screening
Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3
On high dose ICS therapy for \>/= 6 months prior to Visit 1
On an eligible second controller medication for 6 months prior to Visit 1
Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization
Demonstrated adherence with controller medication during the screening period

Criterios de exclusión

History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
Maintenance oral corticosteroid therapy within 3 months prior to Visit 1
Treatment with systemic (oral, intravenous \[IV\], or intramuscular \[IM\]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
Infection that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
History of active tuberculosis requiring treatment
Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
Evidence of acute or chronic hepatitis or known liver cirrhosis
History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma
Diagnosis or history of malignancy or current evaluation for potential malignancy
Current smoker or former smoker with a history of greater than (\>) 10 pack-years
History of alcohol or drug abuse
Past and/or current use of any anti- interleukin (IL) -13 or anti-IL-4/IL-13 therapy, including lebrikizumab
Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1
Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
History of bronchial thermoplasty

Intervenciones

drug

Lebrikizumab

Lebrikizumab will be administered as SC injection at high or low dose Q4W.

drug

Placebo

Lebrikizumab matching placebo will be administered as SC injection Q4W.

drug

Standard of Care

Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists \[LABAs\], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.

Ubicaciones

Centro Médico Vitae

Buenos Aires, Argentina

Fundación Faicep

Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Argentina

INAER

Buenos Aires, Argentina

Instituto Respirar

Mendoza, Argentina

INSARES

Mendoza, Mendoza City, Argentina

Centro Respiratorio Infantil

Rosario, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, Argentina

Instituto Del Buen Aire

Santa Fe, Argentina

Sanatorio Británico de Rosario

Santa Fé, Argentina

CEMER Centro Médico de Enfermedades Respiratorias

Vicente López, Argentina

Estudio de lebrikizumab en participantes adolescentes con asma no controlada que reciben corticosteroides inhalados y un segundo medicamento controlador

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Lebrikizumab

Placebo

Standard of Care

Ubicaciones

Centro Médico Vitae

Fundación Faicep

Fundacion Cidea

INAER

Instituto Respirar

INSARES

Centro Respiratorio Infantil

Investigaciones en Patologias Respiratorias

Centro Integral de Medicina Respiratoria (CIMER)

Instituto Del Buen Aire

Sanatorio Británico de Rosario

CEMER Centro Médico de Enfermedades Respiratorias

Patrocinadores