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
Sites (86)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anima Coordinator of this site? Confirm its status | Alken | Belgium | Not yet recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Emmaues Coordinator of this site? Confirm its status | Mechelen | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Not yet recruiting |
| Medical Center Pulmo - 2018 EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Recruiting |
| Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Coordinator of this site? Confirm its status | Montana | Bulgaria | Recruiting |
| Medical Center Medconsult Pleven OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse Coordinator of this site? Confirm its status | Ruse | Bulgaria | Recruiting |
| Medical center NeoGeneX Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Pulmovision Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Velocity Clinical Research Germany GmbH Coordinator of this site? Confirm its status | Ahrensburg | Germany | Recruiting |
| KPPK GmbH Coordinator of this site? Confirm its status | Bendorf | Germany | Recruiting |
| Clinical Studies Pankow Ishak Teber Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Praxis an der Oper Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Lungenpraxis Hellersdorf – Jens Driemert Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| RCMS/Lungenpraxis Hohenzollerndamm Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Studienzentrum Dr. Keller Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Zentrale für die Koordination von Studien und Vorträgen der Elbpneumologie Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| SLK-Kliniken Heilbronn GmbH Coordinator of this site? Confirm its status | Loewenstein | Germany | Recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Lungenärzte am Rundfunkplatz Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| neumologisches Studienzentrum München-West Coordinator of this site? Confirm its status | München | Germany | Recruiting |
| Petrus-Krankenhaus Coordinator of this site? Confirm its status | Wuppertal | Germany | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
| Hospital Universitario Principe de Asturias Coordinator of this site? Confirm its status | Alcalá de Henares | Spain | Recruiting |
| Hospital Universitario de La Ribera Coordinator of this site? Confirm its status | Alzira | Spain | Recruiting |
| Pectus Respiratory Health S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Vithas Xanit Internacional Coordinator of this site? Confirm its status | Benalmádena | Spain | Recruiting |
| Hospital Universitari de Santa Maria Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital La Milagrosa S.A. Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Recruiting |
| Hospital Universitario Rio Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Coordinator of this site? Confirm its status | Aix En Provence | France | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Recruiting |
| Groupe Hospitalier Du Havre Coordinator of this site? Confirm its status | Montivilliers | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Athens Naval Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Paleo Faliro | Greece | Recruiting |
| Thermi Clinic S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Hajdunanas Varosi Onkormanyzat Coordinator of this site? Confirm its status | Hajdunanas | Hungary | Recruiting |
| Omnimodus Elixír Kft. Coordinator of this site? Confirm its status | Mosonmagyaróvár | Hungary | Recruiting |
| INFER-MED Kft Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Azienda Ospedaliera dei Colli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Sanitaria Locale Di Taranto Coordinator of this site? Confirm its status | Taranto | Italy | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Centrum Medycyny Oddechowej Mroz sp. j. Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Alergologia Plus sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz Coordinator of this site? Confirm its status | Rzeszów | Poland | Recruiting |
| PULMAG s.c. Coordinator of this site? Confirm its status | Sosnowiec | Poland | Recruiting |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Neoclinic Concept S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.