eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation (VIGILANT)

GlaxoSmithKline (GSK)

Status and phase: Enrolling; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Depemokimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07177339

224295

2025-521108-23 (Other Identifier)

Details and patient eligibility

About

Depemokimab is being developed as a treatment for individuals with moderate to severe Chronic Obstructive Pulmonary Disorder (COPD). The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD with type 2 inflammation.

Enrollment: 1,196 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 such as:
  • 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)

Exclusion criteria

• 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

• Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.

• 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

• Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure

• Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,196 participants in 2 patient groups

Depemokimab

Experimental group

Description:

Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).

Treatment:

Drug: Depemokimab

Placebo

Experimental group

Description:

Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.

Treatment:

Drug: Placebo