Transition to KPL-387 Monotherapy Dosing & Administration Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKiniksa Pharmaceuticals International, plc
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KPL-387
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kiniksa Pharmaceuticals International, plc
Lead sponsor
Kiniksa Pharmaceuticals, GmbH
Collaborator
Source ClinicalTrials.gov