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VIGILANT

Depemokimab for COPD with Type 2 Inflammation

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What is being tested

Depemokimab

+ Placebo
Drug
Who is being recruted

Pulmonary Disease, Chronic Obstructive

From 40 to 75 Years
+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorGlaxoSmithKline
Study ContactUS GSK Clinical Trials Call Center
Last updated: September 26, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 20, 2025Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of a medication called depemokimab for people who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with type 2 inflammation. The goal is to see if starting this medicine early can help improve the symptoms and overall health of those affected by this condition. COPD is a long-term lung disease that makes it hard to breathe, and type 2 inflammation is a specific kind of inflammation that can occur in the lungs. By understanding how depemokimab works for these patients, researchers aim to improve treatment options and provide better care for those struggling with this challenging lung disease. Participants in the study will be randomly assigned to receive either depemokimab or a placebo, which is a substance with no active medication, to compare the outcomes. The medication is given as an add-on treatment, meaning it is used alongside the participants' usual COPD treatments. The study is designed to carefully monitor the participants' response to the treatment, looking at improvements in breathing, overall health, and any side effects that may occur. By measuring these factors, the study aims to determine if depemokimab can be a safe and effective option for managing COPD with type 2 inflammation.

Official TitleA 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 
Principal SponsorGlaxoSmithKline
Study ContactUS GSK Clinical Trials Call Center
Last updated: September 26, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1196 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 40 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pulmonary Disease, Chronic Obstructive
Criteria
7 inclusion criteria required to participate
Body mass index (BMI) \>=16 kilograms per square meter (kg/m\^2)
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
Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Screening.
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

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8 exclusion criteria prevent from participating
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
Continuous oxygen: Participants requiring oxygen supplementation for COPD
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
Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).
Group II
Experimental
Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.
Study Objectives
Primary Objectives

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.
Secondary Objectives

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 SGRQ total score will be measured using the SGRQ for COPD \[SGRQ-C\]. The SGRQ-C is a 40-item participant questionnaire designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participants current state (questions 8-14). The questions are designed to be completed by the participant. The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health.

E-RS: COPD consists of 11 items from the 14-item Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcomes (EXACT) instrument. E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, that is, breathlessness, cough, sputum production, chest congestion, and chest tightness. The E-RS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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