This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

Documented physician diagnosis of COPD for at least 12 months
History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
Post-bronchodilator FEV1 \>=20 and \<80% of predicted normal value at screening
Modified Medical Research Council (dyspnea scale) (mMRC) score \>=2
Current or former smoker with a minimum of 10 pack-year history
History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

Criterios de exclusión

Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
History of clinically significant pulmonary disease other than COPD
History of long-term treatment with oxygen at \>4.0 liters/minute
Lung volume reduction surgery or procedure within 12 months prior to screening
Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
History of lung transplant
Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Ubicaciones

Centro Medico IPAM

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Clínicas Belgrano

Buenos Aires, Argentina

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Argentina

Centro Médico Dra de Salvo

Buenos Aires, Argentina

CARE - Centro de Alergia y Enfermedades Respiratorias

CABA, Argentina

Instituto de Medicina Respiratoria, IMeR

Córdoba, Argentina

Centro de Especialidades Medicas Lobos

Lobos, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

INSARES

Mendoza, Argentina

Centro Respiratorio Quilmes

Quilmes, Argentina

Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

Rosario, Argentina

Centro Médico Respire

San Fernando, Argentina

Instituto De Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Argentina

Centro Integral de Medicina Respiratoria (CIMER)

San Miguel de Tucumán, Argentina

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Astegolimab

Placebo

Ubicaciones

Centro Medico IPAM

Centro de Investigaciones Clínicas Belgrano

Instituto de Investigaciones Clinicas-Mar del Plata

Fundacion Cidea

Centro Médico Dra de Salvo

CARE - Centro de Alergia y Enfermedades Respiratorias

Instituto de Medicina Respiratoria, IMeR

Centro de Especialidades Medicas Lobos

Centro de Investigaciones Medicas Mar Del Plata

Instituto Ave Pulmo

INSARES

Centro Respiratorio Quilmes

Instituto Medico Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion Medica

Centro Médico Respire

Instituto De Enfermedades Respiratorias E Investigacion Medica

Investigaciones en Patologias Respiratorias

Centro Integral de Medicina Respiratoria (CIMER)

Patrocinadores