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 — DRUGDepemokimab as a sterile liquid formulation will be administered.
- Placebo — DRUGPlacebo 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: DepemokimabParticipants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).
- Placebo Comparator: PlaceboParticipants 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
- US GSK Clinical Trials Call Center877-379-3718
- EU GSK Clinical Trials Call Center+44 (0) 20 89904466
Locations (55)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Sheffield | Alabama | 35660 | Aaron Karr (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Aurora | Colorado | 80012 | Nathaniel Moore (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Brooksville | Florida | 346135 | Salman Muddassir (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Doral | Florida | 33172 | Felipe Gascon-Rodon (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | Frank Hull (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33122 | Armando Ropero Cartier (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33125 | Ibrahim Menendez-Perez (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33155 | Jacqueline Diaz (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33165 | Ramses Vega (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33175 | Mireya Garcia (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33176 | Juvenal Martinez (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33176 | Ariel Ramirez Navarro (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami Lakes | Florida | 33016 | Eduardo Andre (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Naples | Florida | 34102 | Lisette Delgado Sanchez (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | New Port Richey | Florida | 34653 | Jaime Kratz (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Ocala | Florida | 34471 | Raj Karunakara (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Orlando | Florida | 32825 | Humberto Cruz (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | Dany Obeid (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Palmetto Bay | Florida | 33157 | Luis Hernandez Rosado (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | St. Petersburg | Florida | 33704 | Hudman Hoo (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Adairsville | Georgia | 30103 | John Richmond (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Cordele | Georgia | 31015 | David Kavtaradze (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | East Point | Georgia | 30344 | Ngozika Orjioke (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Morrow | Georgia | 30260 | Marie Walton (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Boise | Idaho | 83702 | Bill Laitinen (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Chicago | Illinois | 60608 | Thomas Wade (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Baton Rouge | Louisiana | 70816 | Alexander Mulamula (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Lafayette | Louisiana | 70506 | Patrick Moore (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Shreveport | Louisiana | 71105 | David Green (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Bangor | Maine | 04401 | Paul Shapero (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Rockville | Maryland | 20854 | Asefa Mekonnen (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Allen Park | Michigan | 48101 | Syed Talib Raza (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Detroit | Michigan | 48202 | Daniel Ouellette (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Garden City | Michigan | 48135 | Renee Dwaihy (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Troy | Michigan | 48085 | Jay Sandberg (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Las Vegas | Nevada | 89144 | Vishisht Mehta (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Moorestown | New Jersey | 08057 | Emilio Mazza (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Sewell | New Jersey | 08080 | Allen Silvey (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Mount Kisco | New York | 10549 | Lisa Youkeles (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | New Windsor | New York | 12553 | Sashi Makam (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Shelby | North Carolina | 28152 | Christian Martin (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | DuBois | Pennsylvania | 15801 | Sandeep Bansal (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | Gerard Criner (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | Farhan Siddiqui (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Union | South Carolina | 29379 | Joseph Boscia (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Knoxville | Tennessee | 37919 | Bashar Bargoty (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Austin | Texas | 78744 | Sean Gilbey (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Dallas | Texas | 75254 | Shakil Ahmed (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | El Paso | Texas | 79902-1123 | Carlo Hatem (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Houston | Texas | 77094 | Murtuza Ahmed (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Lampasas | Texas | 76550 | Vanna Gold (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Richmond | Texas | 77407 | Samira Khan (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | San Antonio | Texas | 78229 | Danielle Coulter (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Webster | Texas | 77598 | Regina Pillai (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Morgantown | West Virginia | 26505-0423 | Ward Paine (PRINCIPAL_INVESTIGATOR) |
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