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.
Sponsors and collaborators
Kiniksa Pharmaceuticals International, plc
Lead sponsor
Kiniksa Pharmaceuticals, GmbH
Collaborator
Source ClinicalTrials.gov