Transition to KPL-387 Monotherapy Dosing & Administration Study (NCT07288216) | Clinical Trial Compass
RecruitingPhase 2
Transition to KPL-387 Monotherapy Dosing & Administration Study
United States80 participantsStarted 2026-03-25
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Key Inclusion Criteria:
* Has well-controlled recurrent pericarditis (i.e., including having CRP \< 0.5 mg/dL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline)
* Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence
* Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept).
Key Exclusion Criteria:
* Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies
* Has had a pericarditis recurrence in the last 3 months prior to Baseline
* Has received an investigational drug during the 4 weeks before study drug administration or is planning to receive an investigational drug at any time during the study.
* Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
* Has a history of immunodeficiency.
* Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
* Has chest x-ray at Screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active TB infection or active infection.
* Has a history of malignancy of any organ system within the past 5 years before Screening (o…
What they're measuring
1
Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
Timeframe: From first administration of study drug up to Week 16
2
Long-Term Extension: Annualized rate of Pericarditis Recurrence through the end of the LTE.