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Looking for participantsPhase2

Transition to KPL-387 Monotherapy Dosing & Administration Study

Sponsor: Kiniksa Pharmaceuticals International, plc

NCT ID: NCT07288216

View on ClinicalTrials.gov ↗

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.

Recurrent PericarditisHeart DiseasesPericarditis

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What we know so far

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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

including positive

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
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.

Where Is This Study? (3 UK sites)

Investigational Site 012

London EC1A 7BE, United Kingdom

Recruiting

Investigational Site 022

London NW3 2QG, United Kingdom

Recruiting

Investigational Site 007

London SE1 7EH, United Kingdom

Recruiting

How to Get in Touch

Clinical Project Manager

Sponsor contact

CONTACT

781-431-9100 clinicaltrials@kiniksa.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06