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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Glaxosmithkline Research & Development Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

19 May 2026 → ongoing

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Research & Development Limited

External identifiers

EU CT number

2025-521108-23-00

ClinicalTrials.gov

NCT07177339

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of depemokimab compared with placebo

Secondary objectives 1

1. To evaluate depemokimab compared with placebo on additional efficacy endpoints and symptoms

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease

Study design 4 periods

Regulatory references

Plan to share IPD

No

IPD plan description

GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents (e.g., Protocol, Statistical Analysis Plan, Clinical Study Report). Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to ‘Sharing Clinical Trial Data’ on the GSK Study Register (www.gsk-studyregister.com)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male or eligible female participants
2. Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
3. 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
4. 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
5. Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening.
6. 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
7. Body mass index (BMI) >=16 kilograms per square meter (kg/m^2)

Exclusion criteria 8

1. 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
2. Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
3. COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1
4. COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1
5. Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure
6. Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
7. 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
8. Continuous oxygen: Participants requiring oxygen supplementation for COPD

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualized rate of moderate/severe exacerbations.

Secondary endpoints 3

1. Time to first moderate/severe exacerbation.
2. Change from baseline in SGRQ total score (measured using the SGRQ-C) at Week 52.
3. Change from baseline in E-RS: COPD total score at Week 52.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Glaxosmithkline Research & Development Limited

Sponsor organisation

Glaxosmithkline Research & Development Limited

Address

79 New Oxford Street

City

London

Postcode

WC1A 1DG

Country

United Kingdom

Scientific contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

Glaxosmithkline Research & Development Limited

Contact name

EU GSK Clinical Trials Call Center

Third parties 11

Locations

12 EU/EEA countries · 78 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 179 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications