At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- KPL-387 (drug)
- How long the study runs
- Study runs about 45 months (dates as stated)
- About the drug or intervention
- KPL-387 — drug: administered by subcutaneous injection
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at moving to KPL-387 on its own (monotherapy) in people with recurrent pericarditis, a condition where the sac around the heart becomes inflamed again and again. It is run by Kiniksa Pharmaceuticals International, plc. The full purpose and design details are not stated — ask the trial team.
Who can take part
- Your recurrent pericarditis is well controlled. This includes a CRP (a blood marker of inflammation) below 0.5 mg/dL within 14 days of the start, and a chest pain score of 3 or less (on a 0–10 number scale) at the start.
- You have had a raised CRP (above 1 mg/dL) during at least one past flare-up of pericarditis.
- You have been treated for recurrent pericarditis for at least 3 months and are on a steady dose of standard medicines. These may include NSAIDs (anti-inflammatory painkillers), colchicine, steroid tablets, or medicines that block a protein in the body called IL-1 (anakinra or rilonacept).
Who may not be able to
- Your pericarditis is caused by certain other specific conditions that are not allowed in this study.
- You have had a pericarditis flare-up in the last 3 months.
- You have taken an experimental (investigational) drug in the 4 weeks before the study drug, or plan to take one during the study.
- You have active tuberculosis (TB), or have had untreated hidden (latent) TB before screening.
- You have a weakened immune system, including a positive HIV test result.
- Your chest X-ray at screening (or within 12 weeks before the first study drug) shows signs of cancer, current or past TB, or an active infection.
- You have had any cancer in the last 5 years, apart from some fully treated skin cancers or an early, non-spreading cancer of the cervix.
- You have a current infection, or a history of long-term or repeated infections (more than 3 episodes in the past year), such as urine, chest, sinus, or skin infections.
- You have had a serious infection, a hospital stay for an infection, or treatment with antibiotics for an infection within 2 weeks before the first study drug.
- You have had an organ transplant, apart from a cornea (eye surface) transplant more than 3 months before the first study drug.
- In the doctor's view, you have another health problem that could affect your taking part or interfere with the study checks.
What taking part involves
- • Taking the study drug KPL-387 on its own (called monotherapy, meaning without your other pericarditis medicines).
- • The exact doses and how the drug is given are not stated — ask the trial team.
Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 120
- Started
- 2026-03-25
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for recurrent pericarditis
- • Phase2 - 120 participants
- • 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
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with recurrent pericarditis
Where?
- • London - Investigational Site 012
- • London - Investigational Site 022
- • London - Investigational Site 007
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
During the Posology (Dosing and Administration) Study, participants on oral pericarditis therapies alone (i.e., non-steroidal anti-inflammatory drugs \[NSAIDs\], colchicine, and/or glucocorticoids) and participants on Interleukin-1 (IL-1) pathway inhibition drugs will transition to KPL-387 per protocol guidelines. Participants will receive KPL-387 for up to 16 weeks in the Posology Study. At study visits throughout the Posology Study, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain numerical rating scale \[NRS\] scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., C-reactive protein \[CRP\]) as well as treatment tolerability and pharmacokinetics (PK). Participants experiencing new or worsening symptoms consistent with pericarditis will be managed per study protocol. All active, enrolled participants in the Posology Study who have not completed an End of Treatment (EOT) Visit may be eligible to transition into the Long-Term Extension (LTE) following completion of the Week 16 Visit. The Week 16 Visit will serve as both a Posology Study End of Study Visit and a Baseline Visit for the LTE. Participants who choose not to participate in the LTE will complete an EOT Visit followed by a Safety Follow-Up until 8 weeks after the last KPL-387 dose administration. The open-label LTE is designed to evaluate the long-term efficacy and safety of KPL-387 in recurrent pericarditis (RP). Treatment in the LTE may continue until the participant has received up to 24 months of treatment in the LTE or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first. At study visits throughout the LTE, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain NRS scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., CRP) as well as treatment tolerability and PK. Participants experiencing new or worsening symptoms consistent with pericarditis will be managed as described in the protocol.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Has well-controlled recurrent pericarditis (i.e., including having CRP \< 0.5 mg/dL within 14 days of Baseline and a...
- ✓Has a documented history of CRP elevation (\> 1 mg/dL) associated with at least one prior acute pericarditis...
Who cannot take part
- ✗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 the study treatment administration or is planning to receive...
- ✗Has a history of active or untreated, latent tuberculosis (TB) prior to screening.
- ✗Has a history of immunodeficiency.
See the full criteria
Where Is This Study? (3 UK sites)
Investigational Site 012
London EC1A 7BE, United Kingdom
Investigational Site 022
London NW3 2QG, United Kingdom
Investigational Site 007
London SE1 7EH, United Kingdom
How to Get in Touch
Clinical Project Manager
Sponsor contactCONTACT
