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

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

NCT06961214

222725

2024-520417-41 (EudraCT Number)

Details and patient eligibility

About

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 compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Enrollment: 960 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 < 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 and eligible female participants

Exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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960 participants in 2 patient groups, including a placebo group

Depemokimab

Experimental group

Description:

Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).

Treatment:

Drug: Depemokimab

Placebo

Placebo Comparator group

Description:

Participants will be administered placebo along with SoC.

Treatment:

Drug: Placebo