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A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

StatusActive, Not Recruiting
PhasePhase 4
SponsorLEO Pharma
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 52 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Jul 23, 2026 to May 13, 2026v52
  2. Sponsor changed: Boehringer Ingelheim to LEO Pharmav51
  3. 3 versions Re-verified since Jun 22, 2026, no change to tracked fieldsv48-v50
  4. Study completion date: Aug 14, 2026 to Sep 2, 2026v47
  5. 5 versions Re-verified since Apr 14, 2026, no change to tracked fieldsv42-v46
Show 39 earlier versionsHide 39 earlier versions
  1. Study sites revised (35)v41
  2. 5 versions Re-verified since Dec 18, 2025, no change to tracked fieldsv36-v40
  3. Study completion date: Nov 5, 2026 to Aug 14, 2026
    • Study sites revised (35)
    v35
  4. Study sites: 34 to 35v34
  5. Study sites revised (34)v33
  6. Re-verified, no change to tracked fieldsv32
  7. Study sites: 33 to 34v31
  8. Study sites: 32 to 33v30
  9. Re-verified, no change to tracked fieldsv29
  10. Study sites: 33 to 32v28
  11. Study sites: 32 to 33v27
  12. Study sites: 33 to 32
    • Start date: Oct 11, 2023 to Oct 22, 2023
    v26
  13. Re-verified, no change to tracked fieldsv25
  14. Enrollment target: estimated 40 to confirmed 42
    • Primary completion date: Dec 24, 2026 to Jul 23, 2026
    • Study completion date: Apr 8, 2027 to Nov 5, 2026
    v24
  15. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 44 to 33
    v23
  16. Study sites: 48 to 44v22
  17. Study sites: 49 to 48v21
  18. Study sites: 51 to 49v20
  19. Site details revised at 20 of 51 sitesv19
  20. Site details revised at 1 of 51 sitesv18
  21. Study sites: 50 to 51v17
  22. Study sites: 46 to 50v16
  23. Study sites: 39 to 46v15
  24. Study sites: 38 to 39v14
  25. Site details revised at 1 of 38 sitesv13
  26. Study sites: 37 to 38v12
  27. Study sites: 33 to 37v11
  28. Study sites: 31 to 33v10
  29. Study sites: 26 to 31v9
  30. Study sites: 21 to 26v8
  31. Study sites: 15 to 21v7
  32. Study sites: 11 to 15v6
  33. Study sites: 6 to 11v5
  34. Study sites: 2 to 6v4
  35. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 17, 2023 to Oct 11, 2023
    v3
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
LEO Pharma
25 trials monitored
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Psoriasis
591 trials monitored
See 24 trials at risk
This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.
Trial Details
NCT Number NCT06013969
Lead Sponsor LEO Pharma
Collaborators: Boehringer Ingelheim
Conditions
(from sponsor)		 Generalized Pustular Psoriasis
Related terms Psoriasis
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov