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

Part of paid clinical trials in Sheffield, Alabama.

Sponsor
GlaxoSmithKline
Study ID
NCT06961214
Phase
PHASE3
Status
Recruiting

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 compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Key Dates

Start date
Jun 23, 2025
Status verified
Apr 2026
Primary completion
Aug 21, 2029
Completion
Aug 21, 2029

Study Design

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

Arms

  • Experimental: Depemokimab
    Participants will be administered subcutaneous (SC) injection of 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 (55)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteSheffieldAlabama35660
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Aaron Karr (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAuroraColorado80012
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Nathaniel Moore (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBrooksvilleFlorida346135
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Salman Muddassir (PRINCIPAL_INVESTIGATOR)
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)
GSK Investigational SiteFort LauderdaleFlorida33316
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Frank Hull (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33122
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Armando Ropero Cartier (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33125
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ibrahim Menendez-Perez (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33155
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Jacqueline Diaz (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33165
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ramses Vega (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33175
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Mireya Garcia (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33176
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Juvenal Martinez (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiamiFlorida33176
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ariel Ramirez Navarro (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMiami LakesFlorida33016
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Eduardo Andre (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNaplesFlorida34102
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Lisette Delgado Sanchez (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew Port RicheyFlorida34653
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Jaime Kratz (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteOcalaFlorida34471
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Raj Karunakara (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteOrlandoFlorida32825
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Humberto Cruz (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteOrmond BeachFlorida32174
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Dany Obeid (PRINCIPAL_INVESTIGATOR)
GSK Investigational SitePalmetto BayFlorida33157
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Luis Hernandez Rosado (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSt. PetersburgFlorida33704
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Hudman Hoo (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAdairsvilleGeorgia30103
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
John Richmond (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteCordeleGeorgia31015
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
David Kavtaradze (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteEast PointGeorgia30344
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ngozika Orjioke (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMorrowGeorgia30260
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Marie Walton (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBoiseIdaho83702
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Bill Laitinen (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteChicagoIllinois60608
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Thomas Wade (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBaton RougeLouisiana70816
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Alexander Mulamula (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteLafayetteLouisiana70506
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Patrick Moore (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteShreveportLouisiana71105
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
David Green (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteBangorMaine04401
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Paul Shapero (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteRockvilleMaryland20854
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Asefa Mekonnen (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAllen ParkMichigan48101
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Syed Talib Raza (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDetroitMichigan48202
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Daniel Ouellette (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteGarden CityMichigan48135
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Renee Dwaihy (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteTroyMichigan48085
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Jay Sandberg (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteLas VegasNevada89144
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Vishisht Mehta (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMoorestownNew Jersey08057
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Emilio Mazza (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSewellNew Jersey08080
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Allen Silvey (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMount KiscoNew York10549
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Lisa Youkeles (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteNew WindsorNew York12553
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Sashi Makam (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteShelbyNorth Carolina28152
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Christian Martin (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDuBoisPennsylvania15801
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Sandeep Bansal (PRINCIPAL_INVESTIGATOR)
GSK Investigational SitePhiladelphiaPennsylvania19140
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Gerard Criner (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSpartanburgSouth Carolina29303
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Farhan Siddiqui (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteUnionSouth Carolina29379
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Joseph Boscia (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteKnoxvilleTennessee37919
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Bashar Bargoty (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAustinTexas78744
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Sean Gilbey (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteDallasTexas75254
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Shakil Ahmed (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteEl PasoTexas79902-1123
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Carlo Hatem (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHoustonTexas77094
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Murtuza Ahmed (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteLampasasTexas76550
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Vanna Gold (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteRichmondTexas77407
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Samira Khan (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteSan AntonioTexas78229
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Danielle Coulter (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWebsterTexas77598
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Regina Pillai (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteMorgantownWest Virginia26505-0423
US GSK Clinical Trials Call Center
877-379-3718
EU GSK Clinical Trials Call Centre
+44 (0) 20 8990 4466
Ward Paine (PRINCIPAL_INVESTIGATOR)

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