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

NCT06959095
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
clinicaltrials.gov
Participants
981
clinicaltrials.gov
Lead sponsor
GlaxoSmithKline
clinicaltrials.gov
Start date
2025-06-20
clinicaltrials.gov
Number of sites
281
clinicaltrials.gov

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.
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Acronym
ENDURA-1
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Short title
Depemokimab as an Extended Treatment Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
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Official title
A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation
clinicaltrials.gov

Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-02-14
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First posted
2025-05-06
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Registry last updated
2026-10-05
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Primary completion date
2028-12-13
clinicaltrials.gov
Start date
2025-06-20
clinicaltrials.gov

Participants
981
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
981
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Protocol amendments
2
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Number of sites
281
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
GlaxoSmithKline
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06959095
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ClinicalTrials.gov ID
NCT06959095
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
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.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Annualized Rate of Moderate/Severe Exacerbations

    Timeframe: From Baseline up to Week 104

    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.

  1. Time to First Moderate/Severe Exacerbation

    Timeframe: From Baseline up to Week 104

    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.

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

    Timeframe: From Baseline up to 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.

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

    Timeframe: From Baseline up to 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 ERS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms.

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

    Timeframe: From Baseline up to Week 104

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

  5. Annualized Rate of Severe Exacerbations

    Timeframe: From Baseline up to Week 104

    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. Annualized rate of severe exacerbations (For pooled analysis across studies 222714 and 222725) will be assessed.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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

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 16 hours per day to maintain resting oxygen saturation greater than 88%
  • 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)
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteBakersfield, United StatesRecruiting
  • GSK Investigational SiteModesto, United StatesRecruiting
  • GSK Investigational SiteNewport Beach, United StatesRecruiting
  • GSK Investigational SiteWilmington, United StatesRecruiting
  • GSK Investigational SiteBradenton, United StatesRecruiting
  • GSK Investigational SiteBrandon, United StatesRecruiting
  • GSK Investigational SiteHialeah, United StatesRecruiting
  • GSK Investigational SiteHialeah, United StatesRecruiting
  • GSK Investigational SiteLoxahatchee Groves, United StatesRecruiting
  • GSK Investigational SiteMiami, United StatesRecruiting
  • GSK Investigational SiteMiami, United StatesRecruiting
  • GSK Investigational SiteMiami Lakes, United StatesRecruiting
  • GSK Investigational SiteOrange City, United StatesRecruiting
  • GSK Investigational SitePalm Springs, United StatesRecruiting
  • GSK Investigational SitePalmetto Bay, United StatesRecruiting
  • GSK Investigational SitePensacola, United StatesRecruiting
  • GSK Investigational SiteTamarac, United StatesRecruiting
  • GSK Investigational SiteTampa, United StatesRecruiting
  • GSK Investigational SiteThe Villages, United StatesRecruiting
  • GSK Investigational SiteRiverdale, United StatesRecruiting
  • GSK Investigational SiteStonecrest, United StatesRecruiting
  • GSK Investigational SiteChicago, United StatesRecruiting
  • GSK Investigational SiteBaltimore, United StatesRecruiting
  • GSK Investigational SiteClarkston, United StatesRecruiting
  • GSK Investigational SiteFlint, United StatesRecruiting

And 256 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-520418-22
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)