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Clinical Trials in the UK / NCT07288216
Recruiting Phase 2

Transition to KPL-387 Monotherapy Dosing & Administration Study

NCT07288216 · tracked via the Priya Life Science UK tracker
Sponsor
Kiniksa Pharmaceuticals International, plc
Phase
Phase 2
Started
2026-03-25
Last updated
2026-08-11

Condition(s) studied

Recurrent PericarditisHeart DiseasesPericarditis

Investigational drug(s) / intervention(s)

KPL-387

KPL-387: administered by subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 episode, whether the incident event or any pericarditis recurrence * Has received treatment for RP for at least 3 months prior to Baseline with standard therapy(ies) and is currently on a stable dosing regimen including NSAIDs and/or colchicine, and/or glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept). Key Exclusion Criteria: * Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies * Has had a pericarditis recurrence in the last 3 months prior to Baseline * Has received an investigational drug during the 4 weeks before study drug administration or is planning to receive an investigational drug at any time during the study. * Has a history of active or untreated, latent tuberculosis (TB) prior to screening. * Has a history of immunodeficiency. * Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results. * 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. * 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). * 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. * 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. * Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration). * 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 (41)

FacilityCityRegionStatus
Investigational Site 031 Phoenix Arizona Recruiting
Investigational Site 014 Los Angeles California Recruiting
Investigational Site 002 Santa Monica California Recruiting
Investigational Site 039 Jacksonville Florida Recruiting
Investigational Site 013 Chicago Illinois Recruiting
Investigational Site 025 Baltimore Maryland Recruiting
Investigational Site 028 Rochester Minnesota Recruiting
Investigational Site 011 New York New York Recruiting
Investigational Site 003 New York New York Recruiting
Investigational Site 009 Cincinnati Ohio Recruiting
Investigational Site 040 Cleveland Ohio Recruiting
Investigational Site 005 Austin Texas Recruiting
Investigational Site 006 Houston Texas Recruiting
Investigational Site 004 Charlottesville Virginia Recruiting
Investigational Site 001 Norfolk Virginia Recruiting
Investigational Site 008 Richmond Virginia Recruiting
Investigational Site 010 Ottawa Ontario Recruiting
Investigational Site 027 Paris France Recruiting
Investigational Site 026 Poitiers France Recruiting
Investigational Site 032 Toulouse France Recruiting
Investigational Site 038 Toulouse France Recruiting
Investigational Site 041 Dresden Germany Recruiting
Investigational Site 035 Athens Greece Recruiting
Investigational Site 023 Nea Ionia Greece Recruiting
Investigational Site 024 Voula Greece Recruiting
Investigational Site 034 Genoa Italy Recruiting
Investigational Site 021 Milan Italy Recruiting
Investigational Site 036 Padua Italy Recruiting
Investigational Site 033 Udine Italy Recruiting
Investigational Site 037 Varese Italy Recruiting
Investigational Site 020 Warsaw Poland Recruiting
Investigational Site 030 Belgrade Serbia Recruiting
Investigational Site 029 Belgrade Serbia Recruiting
Investigational Site 019 Barcelona Spain Recruiting
Investigational Site 015 Barcelona Spain Recruiting
Investigational Site 017 Madrid Spain Recruiting
Investigational Site 016 Madrid Spain Recruiting
Investigational Site 018 Valencia Spain Recruiting
Investigational Site 012 London United Kingdom Recruiting
Investigational Site 022 London United Kingdom Recruiting

+ 1 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 NCT07288216 on ClinicalTrials.gov ↗ ← All trials in the UK