Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

NCT06959095 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2227142024-520418-22
• Study Type: interventional
• Target: 981
• Locations: 3 countries
• Sites: 15

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Depemokimab; GSK3511294; Eosinophilic phenotype; Chronic obstructive pulmonary disease; (COPD); Moderate COPD; Severe COPD; Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease; Exacerbations; Placebo; Type 2 inflammation

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 (i.e., greater than or equal to \[\>=\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.

  From Baseline up to Week 104

Secondary Outcomes (5)

• Time to First Moderate/Severe Exacerbation

  From Baseline up to Week 104

• Change From Baseline in St. Georges Respiratory Questionnaire (SGRQ) Total Score at Week 52

  From Baseline up to Week 52

• Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) Total Score at Week 52

  From Baseline up to Week 52

• Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization

  From Baseline up to Week 104

• Annualized Rate of Severe Exacerbations

  From Baseline up to Week 104

Study Arms (2)

Depemokimab

EXPERIMENTAL

Participants will be administered depemokimab along with standard of care (SoC).

Drug: Depemokimab

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo along with SoC.

Drug: Placebo

Interventions

Depemokimab DRUG

Depemokimab as a sterile liquid formulation will be administered.

Also known as: GSK3511294

Depemokimab

Placebo DRUG

Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be greater than or equal to (\>=) 40 to less than or equal to (\<=) 80 years of age, at the time of signing the informed consent.
• Elevated blood eosinophil count (BEC).
• Moderate to severe COPD with frequent exacerbations, defined as:
• A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
• A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\<) 0.70 and a post- bronchodilator FEV1 \>30 percent (%) and \<= 80% predicted normal values
• A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
• COPD assessment test (CAT) score \>=10 at Visit 1.
• Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years.
• Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1.
• Body mass index (BMI) \>=16 kilogram per square meter (kg/m\^2).
• Male or eligible female participants.

You may not qualify if:

• The following subjects are excluded:
• 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.
• Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening 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 Screening Visit 1.
• Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day.
• Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension
• Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \[BiPAP\] or Continuous Positive Airway Pressure \[CPAP\]).
• Unstable cardiovascular disease or arrhythmia.
• Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Loxahatchee Groves, Florida, 33470, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33155, United States

RECRUITING

GSK Investigational Site

Rock Hill, South Carolina, 29732, United States

RECRUITING

GSK Investigational Site

Corsicana, Texas, 75110, United States

RECRUITING

GSK Investigational Site

Changsha, Hunan, 410015, China

RECRUITING

GSK Investigational Site

Chengdu, Sichuan, China

RECRUITING

GSK Investigational Site

Chengdu, 610041, China

RECRUITING

GSK Investigational Site

Guangzhou, 510150, China

RECRUITING

GSK Investigational Site

Hangzhou, 310000, China

RECRUITING

GSK Investigational Site

Jiangmen, 529000, China

RECRUITING

GSK Investigational Site

Jiangxi, China

RECRUITING

GSK Investigational Site

Mianyang, China

RECRUITING

GSK Investigational Site

Qingyuan, 511500, China

RECRUITING

GSK Investigational Site

Zigong, 643036, China

RECRUITING

GSK Investigational Site

Tokyo, 140-8522, Japan

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 is a double-blind study neither the participants the caregivers the researchers nor the people assessing the outcomes know which treatment is being given to whom.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a placebo-controlled, multicenter trial

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): August 20, 2029
• Study Completion (Estimated): August 20, 2029
• Last Updated: October 8, 2025

Record last verified: 2025-10

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

US (4); CN (10); JP (1)