2023-507093-40-00CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Jun 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 613 (actual)
- First submitted
- 19 Feb 2024
- Start date
- 27 Jan 2022
- Lead sponsor
- Genentech Inc.
- Diseases
- COPD
- EU CT number
- 2023-507093-40-00
- EudraCT number
- 2021-002045-15
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 613
- 84 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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%
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (84)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital | Edegem | Belgium | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| A.Z. Sint-Maarten | Mechelen | Belgium | Completed |
| Pneumocare | Namur | Belgium | Completed |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Completed |
| Medif | Thuin | Belgium | Completed |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Yvoir | Belgium | Completed |
| Asclepius Medical Center OOD | Dupnitsa | Bulgaria | Completed |
| Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Haskovo EOOD | Haskovo | Bulgaria | Completed |
| Medical Centre Leo Clinic | Lovec | Bulgaria | Completed |
| Specializirana Bolnica Za Aktivno Lechenie Na Pnevmo-Ftiziatrichni Zaboliavania Dr Nikola Penchev-Pazardzhik EOOD | Pazardzhik | Bulgaria | Completed |
| Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD | Pernik | Bulgaria | Completed |
| Medical Center Medconsult Pleven OOD | Pleven | Bulgaria | Completed |
| UNIMED Medical Center EOOD | Plovdiv | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD | Plovdiv | Bulgaria | Completed |
| Medical Center Hera EOOD | Sofiya | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov | Sofiya | Bulgaria | Completed |
| Medical Center New Rehabilitation Center EOOD | Stara Zagora | Bulgaria | Completed |
| Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD | Vratsa | Bulgaria | Completed |
| MEDITRIAL s.r.o. | Jindrichuv Hradec III | Czechia | Completed |
| Plicni ambulance Kralupy s.r.o. | Kralupy nad Vltavou | Czechia | Completed |
| MUDr. Ilona Pavlisova s.r.o. | Miroslav | Czechia | Completed |
| KASMED s.r.o. | Tábor | Czechia | Completed |
| Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft | Augsburg | Germany | Completed |
| CIMS Studienzentrum Bamberg GmbH | Bamberg | Germany | Completed |
| KPPK Studienzentrum | Bendorf | Germany | Completed |
| Clinical Studies Pankow | Berlin | Germany | Completed |
| MECS Research GmbH | Berlin | Germany | Completed |
| Medizinisches Versorgungszentrum Jung GbR | Deggingen | Germany | Completed |
| Medizentrum Essen Borbeck | Essen | Germany | Completed |
| Studienzentrum Dr. Keller | Frankfurt | Germany | Completed |
| Asklepios MVZ Bayern GmbH | Landsberg Am Lech | Germany | Completed |
| Salvus-Klinische Studien GmbH | Leipzig | Germany | Completed |
| IKF Pneumologie GmbH & Co. KG | Mainz | Germany | Completed |
| Zentrum fuer ambulante pneumologische Forschung Marburg GbR | Marburg | Germany | Completed |
| Philipps-Universitaet Marburg | Marburg | Germany | Completed |
| Studienzentrum Dr Med Schlenska | Peine | Germany | Completed |
| Aalborg University Hospital | Aalborg | Denmark | Completed |
| Gentofte Hospital | Hellerup | Denmark | Completed |
| Hvidovre Hospital | Hvidovre | Denmark | Completed |
| Odense University Hospital | Odense C | Denmark | Completed |
| Lillebaelt Hospital | Vejle | Denmark | Completed |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Completed |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Completed |
| Hospital Universitario Virgen de las Nieves | Granada | Spain | Completed |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Completed |
| Hospital Clínico San Carlos | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain | Completed |
| Hospital de Mérida | Mérida | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Completed |
| Hospices Civils De Lyon | Lyon Cedex 04 | France | Completed |
| Hôpital Saint Joseph | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice | Nice | France | Completed |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex | France | Completed |
| Amphia Hospital | Breda | Netherlands | Completed |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Completed |
| Dijklander Ziekenhuis | Hoorn Nh | Netherlands | Completed |
| Isala Klinieken Stichting | Zwolle | Netherlands | Completed |
| Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k. | Cracow | Poland | Completed |
| Centrum Medyczne All-Med Badania Kliniczne | Cracow | Poland | Completed |
| Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof Lis | Kielce | Poland | Completed |
| Diamond Clinic sp. z o.o. | Krakow | Poland | Completed |
| ETG ŁÓDŹ | Łódź | Poland | Completed |
| ETG Lublin | Lublin | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. | Nowa Sol | Poland | Completed |
| Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c. | Ostrowiec Świętokrzyski | Poland | Completed |
| Centrum Alergologii Teresa Hofman Sp. z o.o. | Poznan | Poland | Completed |
| EMED Centrum Uslug Medycznych Ewa Smialek | Rzeszów | Poland | Completed |
| ETG Siedlce | Siedlce | Poland | Completed |
| Pulmag Grzegorz Gąsior Marzena Kociołek s.c. | Sosnowiec | Poland | Completed |
| ETG Warszawa | Warszawa | Poland | Completed |
| Michał Bogacki - DOBROSTAN | Wrocław | Poland | Completed |
| Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L. | Brasov | Romania | Completed |
| Fundatia Dr Victor Babes | Bucharest | Romania | Completed |
| Spitalul Clinic de Pneumoftiziologie Leon Daniello | Cluj-Napoca | Romania | Completed |
| Spitalul Clinic De Pneumoftiziologie Constanta | Palazu Mare | Romania | Completed |
| Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" Suceava | Suceava | Romania | Completed |
| Fysikalisk Medicin i Stockholm AB | Lidingö | Sweden | Completed |
| ProbarE i Lund AB | Lund | Sweden | Completed |
| PharmaSite AB | Malmo | Sweden | Completed |
| ProbarE i Stockholm AB | Stockholm | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.