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Transition to KPL-387 Monotherapy Dosing & Administration Study

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment increased: 80 → 120 participants Show 4 more changesShow less
    • Trial sites expanded: 41 → 44 locations
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
  2. Study sites: 39 to 41v11
  3. Trial sites expanded: 33 → 39 locationsv10
  4. Study sites: 32 to 33v9
  5. Trial sites expanded: 23 → 32 locationsv8
  6. Trial sites expanded: 14 → 23 locationsv7
  7. Study sites: 12 to 14v6
  8. Trial sites expanded: 6 → 12 locations
    • Start date changed from estimate of Jan 31, 2026 to Mar 25, 2026
    v5
  9. Study sites: 3 to 6v4
  10. Study sites: 2 to 3v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  12. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.
Trial Details
NCT Number NCT07288216
Lead Sponsor Kiniksa Pharmaceuticals International, plc
Collaborators: Kiniksa Pharmaceuticals, GmbH
Conditions
(from sponsor)		 Recurrent Pericarditis, Heart Diseases, Pericarditis
Related terms Heart Diseases, Pericarditis, Recurrence
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov