Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKiniksa Pharmaceuticals International, plc
About this trial
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Eligibility criteria
Qualifiers
Phase 2 and 3: Has a diagnosis of recurrent pericarditis
Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
Phase 2 and 3: Weighs at least 40 kg
Phase 2: Taking NSAIDS and/or colchicine (in any combination)
Disqualifiers
Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.
Phase 2 and 3: Has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study.
Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
Phase 2 and 3: Has a history of immunodeficiency.
Trial design
Treatments tested in this trial
- KPL-387
- Placebo
Treatment groups
165 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Locations
58Canada
Investigational Site 027K1N 6N5, OttawaOntario, Canada
France
Investigational Site 02834090, Montpellier France
Investigational Site 02175013, Paris France
Investigational Site 03633600, Pessac France
Sponsors and collaborators
Kiniksa Pharmaceuticals International, plc
Lead sponsor
Kiniksa Pharmaceuticals, GmbH
Collaborator
Source ClinicalTrials.gov