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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Depemokimab

    Biological/Vaccine

    Depemokimab as a sterile liquid formulation will be administered.

  • Placebo

    Drug

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

Treatment groups

961 Participants
are divided into 2 treatment groups
Group A: DepemokimabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 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 (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.

Time frame
From Baseline up to Week 104

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 (i.e., greater than or equal to \[\>=\] 24 hours) or result in death.

Time frame
From Baseline up to Week 104
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 participant's current state (questions 8-14). The questions are designed to be self-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 in Chronic Obstructive Pulmonary Disease (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, i.e., 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
4

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

Annualized rate of exacerbations requiring ED Visit or Hospitalization (For pooled analysis across studies 222714 and 222725) will be assessed.

Time frame
From Baseline up to Week 104

Other outcomes

Sponsors and contacts

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