Transition to KPL-387 Monotherapy Dosing & Administration Study

Recruiting Phase 2 Interventional Study
Recurrent Pericarditis Heart Diseases Pericarditis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Kiniksa Pharmaceuticals International, plc · Industry
Who this trial is looking for

This trial is looking for adults who have a recent history of well-controlled recurring chest pain caused by inflammation around the heart. They should have been treated with certain medications for at least three months and currently be stable on those treatments. However, people with certain infections, recent serious illnesses, or specific other health issues are not eligible to join.

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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.

Trial Locations
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Eligibility Criteria
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 …
Contacts

Clinical Project Manager

781-431-9100

clinicaltrials@kiniksa.com

CONTACT