NCT07010159 · Kiniksa Pharmaceuticals International, plc
Phase 2/3 Study of KPL-387 in Recurrent Pericarditis
What this study is about
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
View original scientific description
This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Gilbert, Arizona
- Phoenix, Arizona
- Los Angeles, California
- San Francisco, California
- Santa Monica, California
- Ventura, California
- Westminster, Colorado
- Columbus, Georgia
- Chicago, Illinois
- Indianapolis, Indiana
- Overland Park, Kansas
- Baltimore, Maryland
And 13 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations