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Clinical Trials in the UK / NCT07010159
Recruiting Phase 2/3

Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387

NCT07010159 · tracked via the Priya Life Science UK tracker
Sponsor
Kiniksa Pharmaceuticals International, plc
Phase
Phase 2/3
Started
2025-07-25
Last updated
2026-08-26

Condition(s) studied

PericarditisPericarditis AcuteRecurrent Pericarditis

Investigational drug(s) / intervention(s)

KPL-387Placebo

KPL-387: administered by subcutaneous injection

Placebo: administered by subcutaneous injection

Study summary

This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria: * 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) Key Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (63)

FacilityCityRegionStatus
Investigational Site 018 Gilbert Arizona Recruiting
Investigational Site 053 Phoenix Arizona Recruiting
Investigational Site 030 Los Angeles California Recruiting
Investigational Site 008 San Francisco California Recruiting
Investigational Site 044 Santa Monica California Recruiting
Investigational Site 058 Ventura California Recruiting
Investigational Site 016 Westminster Colorado Recruiting
Investigational Site 061 Washington D.C. District of Columbia Recruiting
Investigational Site 001 Columbus Georgia Withdrawn
Investigational Site 004 Chicago Illinois Recruiting
Investigational Site 014 Indianapolis Indiana Recruiting
Investigational Site 002 Overland Park Kansas Withdrawn
Investigational Site 043 Baltimore Maryland Recruiting
Investigational Site 054 Boston Massachusetts Recruiting
Investigational Site 055 Minneapolis Minnesota Recruiting
Investigational Site 012 Rochester Minnesota Recruiting
Investigational Site 050 Kansas City Missouri Recruiting
Investigational Site 046 Kansas City Missouri Recruiting
Investigational Site 062 St Louis Missouri Recruiting
Investigational Site 015 New York New York Recruiting
Investigational Site 022 New York New York Recruiting
Investigational Site 009 Cincinnati Ohio Recruiting
Investigational Site 003 Cleveland Ohio Recruiting
Investigational Site 005 Austin Texas Recruiting
Investigational Site 013 Houston Texas Recruiting
Investigational Site 042 Burlington Vermont Recruiting
Investigational Site 006 Charlottesville Virginia Recruiting
Investigational Site 023 Norfolk Virginia Recruiting
Investigational Site 045 Richmond Virginia Recruiting
Investigational Site 027 Ottawa Ontario Recruiting
Investigational Site 028 Montpellier France Recruiting
Investigational Site 021 Paris France Recruiting
Investigational Site 036 Pessac France Recruiting
Investigational Site 019 Poitiers France Recruiting
Investigational Site 037 Toulouse France Recruiting
Investigational Site 038 Toulouse France Recruiting
Investigational Site 052 Dresden Germany Recruiting
Investigational Site 034 Athens Greece Recruiting
Investigational Site 039 Nea Ionia Greece Recruiting
Investigational Site 032 Voula Greece Recruiting

+ 23 more sites — see the full list on the official registry below.

More Kiniksa Pharmaceuticals International, plc trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07010159 on ClinicalTrials.gov ↗ ← All trials in the UK