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NCT05878769

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 45 versions: 42 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment reopened
    • Enrollment closed, study ongoing
    • Trial sites reduced: 486 → 480 locations
    • Trial sites expanded: 481 → 486 locations
  2. Trial status: Active, Not Recruiting to Recruiting
    • Eligibility criteria expanded, about 6 words
    • Study sites: 481 to 486
  3. Primary and study completion moved earlier from Jul 1, 2034 to Jun 30, 2027
    • Enrollment closed, study ongoing
    • Trial sites reduced: 486 → 481 locations
    v43
  4. Study sites revised (486)v42
  5. Study sites revised (486)v41
  6. Study sites: 484 to 486v40
  7. Primary and study completion pushed from Jun 30, 2027 to Jul 1, 2034
    • Study sites: 483 to 484
    v39
  8. Study sites: 482 to 483v38
  9. Study sites: 478 to 482v37
  10. Study sites: 462 to 478v36
  11. Site details revised at 6 of 462 sitesv35
  12. Study sites revised (462)v34
  13. Study sites revised (462)v33
  14. Study sites: 459 to 462v32
  15. Site details revised at 3 of 459 sitesv31
  16. Study sites: 458 to 459v30
  17. Study sites: 449 to 458v29
  18. Study sites: 394 to 449v28
  19. Study sites: 376 to 394v27
  20. Study sites: 338 to 376v26
  21. Study sites: 307 to 338v25
  22. Study sites: 280 to 307v24
  23. Study sites: 210 to 280v23
  24. Study sites: 191 to 210v19
  25. Study sites: 180 to 191v18
  26. Study sites: 168 to 180v17
  27. Study sites: 160 to 168v16
  28. Study sites: 156 to 160v15
  29. Study sites: 146 to 156v14
  30. Study sites: 136 to 146v13
  31. Study sites: 124 to 136v12
  32. Study sites: 105 to 124v11
  33. Study sites: 95 to 105v10
  34. Study sites: 70 to 95v9
  35. Study sites: 28 to 70v8
  36. Study sites: 19 to 28v7
  37. Study sites: 16 to 19v6
  38. Study sites: 11 to 16v5
  39. Study sites: 5 to 11v4
  40. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Jul 5, 2023 to Jun 28, 2023
    v3
  41. Start date: Jun 7, 2023 to Jul 5, 2023v2
  42. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of all adverse events (AEs)
Timeframe: Up to 12 weeks after last dose of study treatment

Arms and interventions

Open-Label ExtensionExperimental

Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Drugs: Astegolimab

Sites

480 sites in 40 countries

United States 68, Argentina 40, Poland 36, China 34, Japan 32, Germany 28, Bulgaria 25, Spain 15, South Africa 14, United Kingdom 14, India 13, Israel 13, South Korea 13, Canada 12, Belgium 10, Chile 10, Czechia 10, New Zealand 7, Philippines 7, Denmark 6, France 6, Greece 6, Taiwan 6, Brazil 5, Italy 5, Kenya 5, Netherlands 5, Australia 4, Latvia 4, Mexico 4, Peru 4, Romania 4, Sweden 4, Turkey (Türkiye) 3, Austria 2, Thailand 2, Hong Kong 1, Hungary 1, Puerto Rico 1, Switzerland 1