A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Key facts
- Where
- Bydgoszcz, Cracow, Kielce, Krakow, Łódź, Lublin, Nowa Sol, Ostrowiec Świętokrzyski, Poznan, Rzeszów, Siedlce, Sosnowiec, Warszawa és Wrocław, LengyelországSee the 15 sites
- Phase
- 2. fázis
Where in Lengyelország
- Centrum Medyczne Pratia BydgoszczBydgoszcz, LengyelországNo longer taking part
- Centrum Medyczne All-Med Badania KliniczneCracow, LengyelországNo longer taking part
- Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k.Cracow, LengyelországNo longer taking part
- Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof LisKielce, LengyelországNo longer taking part
- Diamond Clinic sp. z o.o.Krakow, LengyelországNo longer taking part
- ETG ŁÓDŹŁódź, LengyelországNo longer taking part
- ETG LublinLublin, LengyelországNo longer taking part
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.Nowa Sol, LengyelországNo longer taking part
- Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.Ostrowiec Świętokrzyski, LengyelországNo longer taking part
- Centrum Alergologii Teresa Hofman Sp. z o.o.Poznan, LengyelországNo longer taking part
- EMED Centrum Uslug Medycznych Ewa SmialekRzeszów, LengyelországNo longer taking part
- ETG SiedlceSiedlce, LengyelországNo longer taking part
- Pulmag Grzegorz Gąsior Marzena Kociołek s.c.Sosnowiec, LengyelországNo longer taking part
- ETG WarszawaWarszawa, LengyelországNo longer taking part
- Michał Bogacki - DOBROSTANWrocław, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech Inc.
- Trial code
- EU 2023-507093-40-00
- Record updated
- 2025. június 18.
- Original description
To evaluate the effect of astegolimab compared with placebo, on annualized rate of moderate and severe acute exacerbations of COPD over 52 weeks of treatmentRead full original descriptionShow less
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
To evaluate the effect of astegolimab compared with placebo, on annualized rate of moderate and severe acute exacerbations of COPD over 52 weeks of treatment
Inclusion: Age 40-90 years; 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; 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.
Exclusion: Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening; Lung volume reduction surgery or procedure within 12 months prior to screening; 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; History of long-term treatment with oxygen at > 4.0 liters/minute. While breathing supplemental oxygen, patient should demonstrate an oxyhemoglobin saturation of >= 89%; History of clinically significant pulmonary disease other than COPD (e.g. pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency); History of lung transplant.