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NCT07177339RecruitingPhase 3

eValuating the efficacy and safety of InitiatinG depemokImab earLy therApy iN COPD with Type 2 inflammation (VIGILANT)

A multicenter, randomized, double-blind, parallel group, placebo-controlled study of the efficacy and safety of early depemokimab initiation as add-on treatment in COPD patients with type 2 inflammation.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Sept 2026

Brief summary (registry, in English)

To evaluate the efficacy of depemokimab compared with placebo

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
549 (estimated)
First submitted
27 Nov 2025
Start date
19 May 2026
Lead sponsor
Glaxosmithkline Research & Development Limited
Diseases
COPD
NCT number
NCT07177339
EU CT number
2025-521108-23-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 549
  • 86 sites in 12 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, not your situation.

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

  • The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded - Participants with a current or prior physician diagnosis of asthma - Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
  • COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
  • COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
  • Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1

Other illness

  • Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
  • Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure

Other

  • Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded
  • Continuous oxygen: Participants requiring oxygen supplementation for COPD

Who the study is looking for

  • Male or eligible female participants
  • Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
  • Moderate to severe COPD, defined as - A clinically documented history of COPD for at least 1 year - A post-salbutamol Forced expiratory volume in one second (FEV1)/ Forced vital capacity (FVC) ratio of less than (<)0.70 and a post-salbutamol FEV1 greater than (>)30 percent (%) and <80% predicted normal values
  • Elevated risk for exacerbations, defined as - A well-documented history of only 1 moderate COPD exacerbation in the prior 12 months and - The presence of risk factors for future exacerbations/deterioration : ▪ Modified Medical Research Council (mMRC) dyspnea score >= 2 ▪ COPD Assessment Test (CAT) >= 15 ▪ Post-bronchodilator FEV1 < 50% predicted ▪ Chronic bronchitis
  • Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening.
  • Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months
  • Body mass index (BMI) >=16 kilograms per square meter (kg/m^2)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (86)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anima
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AlkenBelgiumNot yet recruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumNot yet recruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumNot yet recruiting
UZ Leuven
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LeuvenBelgiumNot yet recruiting
Emmaues
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MechelenBelgiumNot yet recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Coordinator of this site? Confirm its status
YvoirBelgiumNot yet recruiting
Medical Center Pulmo - 2018 EOOD
Coordinator of this site? Confirm its status
HaskovoBulgariaRecruiting
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Coordinator of this site? Confirm its status
MontanaBulgariaRecruiting
Medical Center Medconsult Pleven OOD
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PlevenBulgariaRecruiting
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
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RuseBulgariaRecruiting
Medical center NeoGeneX Ltd.
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SofiaBulgariaRecruiting
Medical Center Pulmovision Ltd.
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SofiaBulgariaRecruiting
Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD
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SofiaBulgariaRecruiting
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
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SofiyaBulgariaRecruiting
Medical Center Hera EOOD
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SofiyaBulgariaRecruiting
Velocity Clinical Research Germany GmbH
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AhrensburgGermanyRecruiting
KPPK GmbH
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BendorfGermanyRecruiting
Clinical Studies Pankow Ishak Teber
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BerlinGermanyRecruiting
Praxis an der Oper
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BerlinGermanyRecruiting
Lungenpraxis Hellersdorf – Jens Driemert
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BerlinGermanyRecruiting
RCMS/Lungenpraxis Hohenzollerndamm
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BerlinGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Studienzentrum Dr. Keller
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FrankfurtGermanyRecruiting
IKF Pneumologie GmbH & Co. KG
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Frankfurt am MainGermanyRecruiting
Zentrale für die Koordination von Studien und Vorträgen der Elbpneumologie
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HamburgGermanyRecruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyRecruiting
Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
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LeipzigGermanyRecruiting
POIS Sachsen GmbH
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LeipzigGermanyRecruiting
SLK-Kliniken Heilbronn GmbH
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LoewensteinGermanyRecruiting
IKF Pneumologie GmbH & Co. KG
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MainzGermanyRecruiting
Universitaetsklinikum Giessen und Marburg GmbH
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MarburgGermanyRecruiting
Lungenärzte am Rundfunkplatz
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MünchenGermanyRecruiting
neumologisches Studienzentrum München-West
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MünchenGermanyRecruiting
Petrus-Krankenhaus
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WuppertalGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Region Hovedstaden
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HvidovreDenmarkRecruiting
Region Sjaelland
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RoskildeDenmarkRecruiting
Lillebaelt Hospital
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VejleDenmarkRecruiting
Hospital Universitario Principe de Asturias
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Alcalá de HenaresSpainRecruiting
Hospital Universitario de La Ribera
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AlziraSpainRecruiting
Pectus Respiratory Health S.L.
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BarcelonaSpainRecruiting
Hospital Vithas Xanit Internacional
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BenalmádenaSpainRecruiting
Hospital Universitari de Santa Maria
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LleidaSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital La Milagrosa S.A.
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Complexo Hospitalario Universitario de Pontevedra
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PontevedraSpainRecruiting
Hospital Universitario Rio Hortega
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ValladolidSpainRecruiting
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
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Aix En ProvenceFranceRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Groupe Hospitalier Du Havre
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MontivilliersFranceRecruiting
CHRU De Nancy
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Nancy CedexFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceRecruiting
Athens Naval Hospital
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AthensGreeceRecruiting
University General Hospital of Ioannina
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IoanninaGreeceRecruiting
Athens Medical Center S.A.
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MaroussiGreeceRecruiting
Athens Medical Center S.A.
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Paleo FaliroGreeceRecruiting
Thermi Clinic S.A.
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ThessalonikiGreeceRecruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceRecruiting
Hajdunanas Varosi Onkormanyzat
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HajdunanasHungaryRecruiting
Omnimodus Elixír Kft.
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MosonmagyaróvárHungaryRecruiting
INFER-MED Kft
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PécsHungaryRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
Azienda Ospedaliera dei Colli
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NaplesItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Sanitaria Locale Di Taranto
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TarantoItalyRecruiting
Amphia Hospital
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BredaNetherlandsRecruiting
Medisch Spectrum Twente
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EnschedeNetherlandsRecruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsRecruiting
Centrum Medycyny Oddechowej Mroz sp. j.
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BialystokPolandRecruiting
Santa SP. z o.o
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LodzPolandRecruiting
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
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PoznanPolandRecruiting
Alergologia Plus sp. z o.o.
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PoznanPolandRecruiting
Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz
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RzeszówPolandRecruiting
PULMAG s.c.
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SosnowiecPolandRecruiting
Delta Health Care S.R.L
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BucharestRomaniaRecruiting
Neoclinic Concept S.R.L.
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TimisoaraRomaniaRecruiting
Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin
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TimisoaraRomaniaRecruiting

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