Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)

Part of paid clinical trials in Loxahatchee Groves, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT06959095
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Depemokimab — DRUG
    Depemokimab as a sterile liquid formulation will be administered.
  • Placebo — DRUG
    Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Oct 2025
Primary completion
Aug 20, 2029
Completion
Aug 20, 2029

Study Design

Enrollment
981 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Depemokimab
    Participants will be administered depemokimab along with standard of care (SoC).
  • Placebo Comparator: Placebo
    Participants will be administered placebo along with SoC.

Primary Outcome Measure

Annualized Rate of Moderate/Severe Exacerbations [ Time Frame: From Baseline up to Week 104 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLoxahatchee GrovesFlorida33470
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Neal Warshoff (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33155
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Guillermo Somodevilla (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteRock HillSouth Carolina29732
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Michael Denenberg (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteCorsicanaTexas75110
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
John D Updegrove (PRINCIPAL_INVESTIGATOR)

Find similar trials in Loxahatchee Groves, FL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
GSK Investigational Site· Loxahatchee Groves, FLGSK Investigational Site· Miami, FLGSK Investigational Site· Rock Hill, SCGSK Investigational Site· Corsicana, TX

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