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

Part of paid clinical trials in Doral, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT07177339
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Depemokimab — DRUG
    Depemokimab will be administered.
  • Placebo — DRUG
    Matching placebo will be administered.

Study Details

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.

Key Dates

Start date
Oct 20, 2025
Status verified
Nov 2025
Primary completion
Nov 2, 2029
Completion
Dec 14, 2029

Study Design

Enrollment
1,196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Depemokimab
    Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (SoC).
  • Experimental: Placebo
    Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.

Primary Outcome Measure

Annualized Rate of Moderate/Severe Exacerbations [ Time Frame: From Baseline Up to Week 156 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteDoralFlorida33172
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Felipe Gascon-Rodon (PRINCIPAL_INVESTIGATOR)

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