Last updated: 07/02/2025 10:40:18

Depemokimab as an Extended treatmeNt Duration biologic in Adults with Chronic Obstructive Pulmonary Disease (COPD) and type 2 inflammation (ENDURA-2)ENDURA-2

GSK study ID
222725
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Annualized Rate of Moderate/Severe Exacerbations

Timeframe: From Baseline up to Week 104

Secondary outcomes:

Time to First Moderate/Severe Exacerbation

Timeframe: From Baseline up to Week 104

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

Timeframe: From Baseline up to Week 52

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

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

Timeframe: From Baseline up to Week 104

Annualized Rate of Severe Exacerbations

Timeframe: From Baseline up to Week 104

Interventions:
  • Drug: Depemokimab
  • Drug: Placebo
  • Enrollment:
    960
    Primary completion date:
    2029-21-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    June 2025 to August 2029
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 80 Years
    Accepts 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)
    • The following subjects are excluded:
    • Participants with a current or prior physician diagnosis of asthma

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Orlando, FL, United States, 32825
    Status
    Recruiting

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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