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NCT05851443

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Inadequately Controlled Moderate to Severe Asthma

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

The 50 most recent of 79 versions: 49 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruitingv79 Show 4 more changesShow less
    • Primary completion pushed from Jun 15, 2026 to Nov 20, 2026
    • Study completion pushed from Jan 31, 2027 to Jul 5, 2027
    • Enrollment target: estimated 240 to confirmed 247
    • Study sites: 83 to 82
  2. Study sites: 84 to 83v78
  3. Site details revised at 1 of 84 sitesv77
  4. Site details revised at 1 of 84 sitesv76
  5. Site details revised at 1 of 84 sitesv75
Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 1 of 84 sitesv74
  2. Site details revised at 2 of 84 sitesv73
  3. Study sites revised (84)v72
  4. Site details revised at 3 of 84 sitesv70
  5. Primary completion date: Oct 15, 2025 to Jun 15, 2026
    • Study completion date: May 29, 2026 to Jan 31, 2027
    • Site details revised at 1 of 84 sites
    v69
  6. Site details revised at 2 of 84 sitesv68
  7. Site details revised at 1 of 84 sitesv67
  8. Site details revised at 1 of 84 sitesv66
  9. Site details revised at 4 of 84 sitesv65
  10. Site details revised at 1 of 84 sitesv64
  11. Site details revised at 2 of 84 sitesv63
  12. Site details revised at 1 of 84 sitesv62
  13. Site details revised at 1 of 84 sitesv61
  14. Site details revised at 1 of 84 sitesv60
  15. Site details revised at 2 of 84 sitesv59
  16. Site details revised at 3 of 84 sitesv58
  17. Site details revised at 1 of 84 sitesv57
  18. Site details revised at 1 of 84 sitesv56
  19. Site details revised at 1 of 84 sitesv55
  20. Site details revised at 1 of 84 sitesv54
  21. Site details revised at 2 of 84 sitesv53
  22. Study sites revised (84)v52
  23. Site details revised at 2 of 84 sitesv51
  24. Site details revised at 4 of 84 sitesv50
  25. Site details revised at 5 of 84 sitesv49
  26. Primary completion date: Dec 20, 2024 to Oct 15, 2025
    • Eligibility criteria shortened, about 78 words
    • Study sites: 92 to 84
    • Study completion date: Aug 8, 2025 to May 29, 2026
    v48
  27. Site details revised at 1 of 92 sitesv47
  28. Study sites: 101 to 92v46
  29. Site details revised at 1 of 101 sitesv45
  30. Study sites: 100 to 101v44
  31. Site details revised at 1 of 100 sitesv43
  32. Site details revised at 2 of 100 sitesv42
  33. Study sites: 99 to 100v41
  34. Site details revised at 1 of 99 sitesv40
  35. Site details revised at 6 of 99 sitesv39
  36. Study sites: 97 to 99v38
  37. Site details revised at 2 of 97 sitesv37
  38. Study sites: 96 to 97v36
  39. Site details revised at 1 of 96 sitesv35
  40. Study sites: 95 to 96v34
  41. Site details revised at 1 of 95 sitesv33
  42. Site details revised at 2 of 95 sitesv32
  43. Site details revised at 1 of 95 sitesv31
  44. Site details revised at 1 of 95 sitesv30
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Absolute change in pre-bronchodilator forced expiratory volume in the first 1 second (pre-BD FEV1)
Timeframe: Baseline ; Week 24

Secondary (7)

Number of asthma exacerbations during the Placebo Controlled (PC) period
Absolute change from baseline in pre-BD FEV1 at each visit
Percent change from baseline in pre-BD FEV1 at each visit
Absolute change from baseline in post-BD FEV1 at week 24
Percent change from baseline in post-BD FEV1 at week 24
Show 2 moreShow less
Absolute change from baseline in pre-BD FVC at each visit
Percent change from baseline in pre-BD FVC at each visit

Arms and interventions

Inhaled Corticoseroid Long Acting Beta-Agonist(ICS-LABA) + placeboPlacebo comparator

Participants will receive stable background therapy with ICS-LABA in combination with placebo once daily (QD) for 24 weeks during the placebo-controlled period. Participants will be allocated to 1 of 3 doses of povorcitinib during the extension period of 28 weeks

ICS-LABA + povorcitinib Dose 1Experimental

Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 1 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks

ICS-LABA + povorcitinib Dose 2Experimental

Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 2 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks

ICS-LABA + povorcitinib Dose 3Experimental

Participants will receive stable background therapy with ICS-LABA in combination with povorcitinib dose 3 once daily (QD) for 24 weeks during the placebo-controlled period, and Participants will continue to take the same dose of povorcitinib during the extension period of 28 weeks

Drugs: povorcitinib, ICS-LABA

Other: placebo

Sites

82 sites in 7 countries

United States 26, Argentina 22, Japan 15, Canada 6, Poland 6, Germany 5, Spain 2