RecruitingPhase 2Phase 3NCT07010159
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis
Sponsor
Kiniksa Pharmaceuticals International, plc
Enrollment
165 participants
Start Date
Jul 25, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria5
- 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)
- Phase 3: Taking NSAIDs and/or colchicine and/or glucocorticoids (in any combination)
Exclusion Criteria11
- 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.
- Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.
- Phase 2 and 3: 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.
- Phase 2 and 3: Has a history of malignancy of any organ system within the past 5 years before Screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix).
- Phase 2 and 3: Has a known or suspected current active infection or a history of chronic or recurrent infectious disease (\> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection.
- Phase 2 and 3: Has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration.
- Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).
- Phase 2 and 3: In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGKPL-387
administered by subcutaneous injection
DRUGPlacebo
administered by subcutaneous injection
Locations(46)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07010159
Related Trials
CACP: Study on Camptodactyly - Arthropathy - Coxa Vara - Pericarditis (CACP) Syndrome
NCT0746846110 locations
CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3)
NCT0670829926 locations
Transition to KPL-387 Monotherapy Dosing & Administration Study
NCT072882166 locations
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
NCT0683623216 locations
COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry
NCT050460021 location