Last updated 6 days ago

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

1290 patients around the world

Available in Spain, United States, Argentina

Hoffmann-La Roche

20Research sites

1290Patients around the world

This study is for people with

Chronic obstructive pulmonary disease

Copd

To 80 Years

All Gender

: Documented COPD diagnosis for ≥ 12 months
History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening
Post-bronchodilator FEV1/FVC < 0.70 at screening
Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2
Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years
On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening:
Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD

: Current documented diagnosis of asthma
History of clinically significant pulmonary disease other than COPD
Diagnosis of 1-antitrypsin deficiency
History of long-term treatment with oxygen at > 4.0 liters/minute
Lung volume reduction surgery or procedure within 12 months prior to screening
Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
History of lung transplant
Any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
Upper or lower respiratory tract infection within 4 weeks prior to or during screening
Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months 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

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Viamonte, Cdad. Autónoma de Buenos Aires, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires

Arenales 3146, CABA, Buenos Aires

Instituto del Buen Aire

Junín 2370, Santa Fe

Sala de Primeros Auxilios Alberto Mignaburu - Berazategui, Prov Buenos Aires

Av. Antartida Argentina entre calle 257 y camino Gral Belgrano S/N, Berazategui Buenos Aires

Servicio de Investigación de Patologías Alérgicas del Instituto ABC

Salta 2668, Rosario, Santa Fe

Centro Médico Capital

Av. 60 462, B1904 La Plata, Provincia de Buenos Aires

Centro Médico Framingham

Calle 9 Nro 431, La Plata, Buenos Aires

Instituto Médico Platense SA - La Plata

Boulevard 51 Nro 315, La Plata, Buenos Aires

Centro Médico Dharma

República de Siria 271, Mendoza

Centro Privado de Medicina Respiratoria - CPMR

esquina Prov. de, Petrona Rosende 2394, E3100 Paraná, Entre Ríos, Argentina

StudyARNASA

SponsorHoffmann-La Roche

Study typeInterventional

Conditions

Copd

Requirements

To 80 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05595642