Last updated: 11/24/2025 05:21:52
eValuating the efficacy and safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammationVIGILANT
GSK study ID
224295
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Annualized Rate of Moderate/Severe Exacerbations
Timeframe: From Baseline Up to Week 156
Secondary outcomes:
Time to First Moderate/Severe Exacerbation
Timeframe: From Baseline Up to Week 156
Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 52
Timeframe: From Baseline up to Week 52
Change from Baseline in Evaluating Respiratory Symptoms (E-RS): COPD Total Score at Week 52
Timeframe: From Baseline up to Week 52
Interventions:
Drug: Depemokimab
Drug: Placebo
Enrollment:
1196
Observational study model:
Not applicable
Primary completion date:
2029-02-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to December 2029
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 75 Years
Accepts healthy volunteers
No
- Male or eligible female participants
- Eosinophilic phenotype measured using Blood Eosinophil Count (BEC)
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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
- 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
- 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)
Male or eligible female participants
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
Chronic bronchitis
Exclusion criteria:
- Participants with a current or prior physician diagnosis of asthma
- 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
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 childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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