A Phase 2 Posology Study with Long-Term Extension in Participants with Well‑Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy from Standard Therapies

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523234-66-00

Enrollment

Registered

2026-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-Controlled Recurrent Pericarditis

Brief summary

Primary Efficacy Endpoint – Posology Study: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence., Primary Efficacy Endpoint – LTE: Annualized rate of Pericarditis Recurrence through the end of the LTE. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE.

Interventions

DRUGKPL-387

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint – Posology Study: Proportion of participants free from Pericarditis Recurrence by Week 16. Only Clinical Endpoint Committee (CEC) confirmed Pericarditis Recurrences will be considered as events for establishment of freedom from Pericarditis Recurrence., Primary Efficacy Endpoint – LTE: Annualized rate of Pericarditis Recurrence through the end of the LTE. Only CEC-confirmed Pericarditis Recurrences will be considered as events for the analysis in the LTE.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 21, 2026