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Recruiting Phase 3 NCT05595642

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

Phase 3 – large-scale trial before approval
Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
Who can participate
Inclusion Criteria * 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: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA * 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 Exclusion Criteria * 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
Locations 35
Argentina (1)
Consultorios Medicos Organizacion de Buen Ayre SRL
Buenos Aires
COMPLETED
Australia (1)
Institute for Respiratory Health - Midland
Midland , South Australia
COMPLETED
Belgium (1)
AZ Sint-Jan Brugge-Oostende
Bruges
COMPLETED
Brazil (1)
CEDOES - Diagnóstico e Pesquisa
Vitória , Espírito Santo
WITHDRAWN
Bulgaria (1)
Multiprofile Hospital for Active Treatment Puls AD PPDS
Blagoevgrad
COMPLETED
Canada (1)
Edmonton Respiratory Consultants
Edmonton , Alberta
COMPLETED
Chile (1)
Centro Respiratorio Integral LTDA. (CENRESIN)
Pavie Gallegos
COMPLETED
China (1)
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou , Guangdong
COMPLETED
Czech Republic (1)
Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav
COMPLETED
Denmark (1)
Naestved Sygehus
Næstved
COMPLETED
France (1)
Sas Clinique De L Europe - Amiens
Amiens
COMPLETED
Greece (1)
University General Hospital of Alexandroupolis
Alexandroupoli
WITHDRAWN
Hong Kong (1)
Queen Mary Hospital
Hong Kong
WITHDRAWN
Hungary (1)
Benyovszky Medical Center
Budapest
COMPLETED
India (1)
Paarthiv Lung Care Center
Hyderabad , Andhra Pradesh
COMPLETED
Israel (1)
Soroka University Medical Centre
Beersheba
COMPLETED
Italy (1)
Presidio Ospedaliero Santa Maria della Speranza
Battipaglia , Campania
COMPLETED
Japan (1)
Makita Hospital
Sapporo , Hokkaido
Kenya (1)
KEMRI-MTWAPA Clinical Trial Site
Kilifi , Coast
COMPLETED
Latvia (1)
Health Center Association, Medical Center OLVI
Daugavpils
WITHDRAWN
Netherlands (1)
Meander Medisch Centrum
Amersfoort
COMPLETED
New Zealand (1)
Greenlane Clinical Centre
Auckland
COMPLETED
Philippines (1)
Manila Central University-Filemon D Tanchoco Medical Foundation
Caloocan
COMPLETED
Poland (1)
CenterMed Sp. z o.o.
Tarnów , Lesser Poland Voivodeship
COMPLETED
Puerto Rico (1)
Allianze Pulmonary Research LLC
Guaynabo
COMPLETED
Romania (1)
Cardos Rosca Medical S.R.L.
Cluj-Napoca
WITHDRAWN
South Africa (1)
Iatros International
Bloemfontein , Free State
COMPLETED
South Korea (1)
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
COMPLETED
Spain (1)
Hospital Universitario Son Espases
Palma de Mallorca , Balearic Islands
COMPLETED
Sweden (1)
Clinical Trial Consultants - Linkoping
Uppsala , Uppsala County
COMPLETED
Taiwan (1)
Changhua Christian Hospital
Chang-hua
COMPLETED
Thailand (1)
Chulalongkorn University
Bangkok
WITHDRAWN
Turkey (1)
Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
Istanbul
WITHDRAWN
United Kingdom (1)
Castle Hill Hospital
Cottingham , Yorkshire
COMPLETED
United States (1)
Pinnacle Research Group
Anniston , Alabama
WITHDRAWN
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
29.12.2022
Completion date
24.09.2027
Registry ID
NCT05595642
Source
anzctr
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