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

RecruitingPhase 2/3

A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis

Who can join

Ages 18 to 80 · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Kiniksa Pharmaceuticals International, plc · Participants: 325 · Started: Jul 25, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07010159

Locations in the U.S.

ArizonaInvestigational Site 018, Gilbert
Investigational Site 053, Phoenix
CaliforniaInvestigational Site 030, Los Angeles
Investigational Site 008, San Francisco
Investigational Site 044, Santa Monica
Investigational Site 058, Ventura
ColoradoInvestigational Site 016, Westminster
District of ColumbiaInvestigational Site 061, Washington D.C.
IllinoisInvestigational Site 004, Chicago
IndianaInvestigational Site 014, Indianapolis
MarylandInvestigational Site 043, Baltimore
MassachusettsInvestigational Site 054, Boston
MinnesotaInvestigational Site 055, Minneapolis
Investigational Site 012, Rochester
MissouriInvestigational Site 046, Kansas City
Investigational Site 050, Kansas City
Investigational Site 062, St Louis
New YorkInvestigational Site 015, New York
Investigational Site 022, New York
OhioInvestigational Site 009, Cincinnati
Investigational Site 003, Cleveland
TexasInvestigational Site 005, Austin
Investigational Site 013, Houston
VermontInvestigational Site 042, Burlington
VirginiaInvestigational Site 006, Charlottesville
Investigational Site 023, Norfolk
Investigational Site 045, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.