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

NCT07177339 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2242952025-521108-23
• Study Type: interventional
• Target: 1,196
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Depemokimab; Chronic Obstructive Pulmonary Disorder; COPD; Type 2 inflammation; Eosinophilic phenotype; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Moderate/Severe Exacerbations

  Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized rate of moderate or severe exacerbations will be reported.

  From Baseline Up to Week 156

Secondary Outcomes (3)

• Time to First Moderate/Severe Exacerbation

  From Baseline Up to Week 156

• Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

  From Baseline up to Week 52

• Change from Baseline in Evaluating Respiratory Symptoms (E-RS): COPD Total Score at Week 52

  From Baseline up to Week 52

Study Arms (2)

Depemokimab

EXPERIMENTAL

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

Drug: Depemokimab

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Depemokimab DRUG

Depemokimab will be administered.

Depemokimab

Placebo DRUG

Matching placebo will be administered.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Doral, Florida, 33172, United States

RECRUITING

GSK Investigational Site

Chengdu, 610041, China

RECRUITING

GSK Investigational Site

Guilin, 541002, China

RECRUITING

GSK Investigational Site

Jiangmen, 529100, China

RECRUITING

GSK Investigational Site

Nanchang, 330000, China

RECRUITING

GSK Investigational Site

Taizhou, 317000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double-blind study in which participants care providers investigators and outcome assessors will be blinded to the study intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 17, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): November 2, 2029
• Study Completion (Estimated): December 14, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

CN (5); US (1)