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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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (84)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Antwerp University HospitalEdegemBelgiumCompleted
UZ LeuvenLeuvenBelgiumCompleted
A.Z. Sint-MaartenMechelenBelgiumCompleted
PneumocareNamurBelgiumCompleted
Algemeen Ziekenhuis DeltaRoeselareBelgiumCompleted
MedifThuinBelgiumCompleted
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurYvoirBelgiumCompleted
Asclepius Medical Center OODDupnitsaBulgariaCompleted
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Haskovo EOODHaskovoBulgariaCompleted
Medical Centre Leo ClinicLovecBulgariaCompleted
Specializirana Bolnica Za Aktivno Lechenie Na Pnevmo-Ftiziatrichni Zaboliavania Dr Nikola Penchev-Pazardzhik EOODPazardzhikBulgariaCompleted
Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOODPernikBulgariaCompleted
Medical Center Medconsult Pleven OODPlevenBulgariaCompleted
UNIMED Medical Center EOODPlovdivBulgariaCompleted
University Multiprofile Hospital For Active Treatment Saint Georgi EADPlovdivBulgariaCompleted
Medical Center Hera EOODSofiyaBulgariaCompleted
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I PirogovSofiyaBulgariaCompleted
Medical Center New Rehabilitation Center EOODStara ZagoraBulgariaCompleted
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOODVratsaBulgariaCompleted
MEDITRIAL s.r.o.Jindrichuv Hradec IIICzechiaCompleted
Plicni ambulance Kralupy s.r.o.Kralupy nad VltavouCzechiaCompleted
MUDr. Ilona Pavlisova s.r.o.MiroslavCzechiaCompleted
KASMED s.r.o.TáborCzechiaCompleted
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok PartnerschaftAugsburgGermanyCompleted
CIMS Studienzentrum Bamberg GmbHBambergGermanyCompleted
KPPK StudienzentrumBendorfGermanyCompleted
Clinical Studies PankowBerlinGermanyCompleted
MECS Research GmbHBerlinGermanyCompleted
Medizinisches Versorgungszentrum Jung GbRDeggingenGermanyCompleted
Medizentrum Essen BorbeckEssenGermanyCompleted
Studienzentrum Dr. KellerFrankfurtGermanyCompleted
Asklepios MVZ Bayern GmbHLandsberg Am LechGermanyCompleted
Salvus-Klinische Studien GmbHLeipzigGermanyCompleted
IKF Pneumologie GmbH & Co. KGMainzGermanyCompleted
Zentrum fuer ambulante pneumologische Forschung Marburg GbRMarburgGermanyCompleted
Philipps-Universitaet MarburgMarburgGermanyCompleted
Studienzentrum Dr Med SchlenskaPeineGermanyCompleted
Aalborg University HospitalAalborgDenmarkCompleted
Gentofte HospitalHellerupDenmarkCompleted
Hvidovre HospitalHvidovreDenmarkCompleted
Odense University HospitalOdense CDenmarkCompleted
Lillebaelt HospitalVejleDenmarkCompleted
Hospital de la Santa Creu i Sant PauBarcelonaSpainCompleted
Hospital San Pedro De AlcántaraCáceresSpainCompleted
Hospital Universitario Virgen de las NievesGranadaSpainCompleted
Hospital General Universitario Gregorio MarañónMadridSpainCompleted
Hospital Clínico San CarlosMadridSpainCompleted
Hospital Universitario Fundación Jiménez DíazMadridSpainCompleted
Hospital Universitario Virgen de la VictoriaMálagaSpainCompleted
Hospital de MéridaMéridaSpainCompleted
Hospital Universitario Marqués de ValdecillaSantanderSpainCompleted
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpainCompleted
Hospices Civils De LyonLyon Cedex 04FranceCompleted
Hôpital Saint JosephMarseilleFranceCompleted
Centre Hospitalier Universitaire de NiceNiceFranceCompleted
Les Hopitaux Universitaires De StrasbourgStrasbourg CedexFranceCompleted
Amphia HospitalBredaNetherlandsCompleted
Catharina Ziekenhuis StichtingEindhovenNetherlandsCompleted
Dijklander ZiekenhuisHoorn NhNetherlandsCompleted
Isala Klinieken StichtingZwolleNetherlandsCompleted
Centrum Medyczne Pratia BydgoszczBydgoszczPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k.CracowPolandCompleted
Centrum Medyczne All-Med Badania KliniczneCracowPolandCompleted
Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof LisKielcePolandCompleted
Diamond Clinic sp. z o.o.KrakowPolandCompleted
ETG ŁÓDŹŁódźPolandCompleted
ETG LublinLublinPolandCompleted
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.Nowa SolPolandCompleted
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.Ostrowiec ŚwiętokrzyskiPolandCompleted
Centrum Alergologii Teresa Hofman Sp. z o.o.PoznanPolandCompleted
EMED Centrum Uslug Medycznych Ewa SmialekRzeszówPolandCompleted
ETG SiedlceSiedlcePolandCompleted
Pulmag Grzegorz Gąsior Marzena Kociołek s.c.SosnowiecPolandCompleted
ETG WarszawaWarszawaPolandCompleted
Michał Bogacki - DOBROSTANWrocławPolandCompleted
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.BrasovRomaniaCompleted
Fundatia Dr Victor BabesBucharestRomaniaCompleted
Spitalul Clinic de Pneumoftiziologie Leon DanielloCluj-NapocaRomaniaCompleted
Spitalul Clinic De Pneumoftiziologie ConstantaPalazu MareRomaniaCompleted
Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" SuceavaSuceavaRomaniaCompleted
Fysikalisk Medicin i Stockholm ABLidingöSwedenCompleted
ProbarE i Lund ABLundSwedenCompleted
PharmaSite ABMalmoSwedenCompleted
ProbarE i Stockholm ABStockholmSwedenCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.