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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-75
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Depemokimab

    Drug

    Depemokimab will be administered.

  • Placebo

    Drug

    Matching placebo will be administered.

Treatment groups

1,196 Participants
are divided into 2 treatment groups
Group A: DepemokimabExperimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From Baseline Up to Week 156

Secondary outcomes

1

Time to First Moderate/Severe Exacerbation

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.

Time frame
From Baseline Up to Week 156
2

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

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.

Time frame
From Baseline up to Week 52
3

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

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.

Time frame
From Baseline up to Week 52

Other outcomes

Sponsors and contacts

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