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Looking for participantsPhase2/Phase3

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

Sponsor: Kiniksa Pharmaceuticals International, plc

NCT ID: NCT07010159

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), Placebo (drug)
How long the study runs
Study runs about 53 months (dates as stated)
About the drug or intervention
KPL-387 — drug: administered by subcutaneous injection · Placebo — drug: administered by subcutaneous injection
Patient visit burden
Not specified by the sponsor

In plain English

This is a phase 2/3 study testing a medicine called KPL-387 for people with recurrent pericarditis, which is when the lining around the heart becomes inflamed again and again. The study is looking at how well the medicine works and how safe it is. It is run by Kiniksa Pharmaceuticals International, plc.

Who can take part

  • Has a diagnosis of recurrent pericarditis
  • Still has signs and symptoms of recurrent pericarditis despite treatment with standard therapies
  • Weighs at least 40 kg
  • For phase 2: taking anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs, or NSAIDs) and/or colchicine in any combination
  • For phase 3: taking NSAIDs and/or colchicine and/or glucocorticoids (steroid medicines) in any combination

Who may not be able to

  • Pericarditis caused by certain specific conditions that are not allowed in this study
  • Has taken an experimental (investigational) drug in the 4 weeks before screening, or plans to take one during the study
  • Has a history of active tuberculosis (TB), or untreated hidden (latent) TB
  • Has a history of immunodeficiency or immunosuppression, including a positive HIV test
  • Has a chest x-ray showing cancer, signs of past or active TB, or active infection
  • Has had any cancer in the past 5 years, apart from some successfully treated skin cancers and early cervical cancer that has not spread
  • Has an active infection now, or a history of long-term or repeated infections (more than 3 episodes in the past year)
  • Has had a serious infection, a hospital stay for infection, or antibiotic treatment for an infection within 2 weeks of the first study drug
  • Has had an organ transplant, except a cornea transplant more than 3 months before the first study drug
  • Has any other medical condition that, in the researcher's view, could affect taking part or interfere with the study checks

What taking part involves

  • • Not stated — ask the trial team
  • • The study drug is called KPL-387

Time commitment: Not stated — ask the trial team

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
325
Started
2025-07-25
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for pericarditis
  • • Phase2/Phase3 - 325 participants
  • • This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with pericarditis

Where?

  • • London - Investigational Site 020
  • • London - Investigational Site 047
  • • London - Investigational Site 035
  • • Southampton - Investigational Site 017

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

This clinical trial is comprised of 3 separate study parts: Phase 2, Phase 3, and Long-Term Extension. The primary objective of Phase 2 is to evaluate how well different dose levels of KPL-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. This part of the study will confirm the KPL-387 dose level to be further tested in Phase 3 and the Long-Term Extension. The primary objective of Phase 3 is to confirm the efficacy of KPL-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. Participants who complete Phase 2 or Phase 3 may be eligible to participate in the Long-Term Extension. The primary objective of the Long-Term Extension is to assess the long-term efficacy of KPL-387 while maintaining long-term disease control. All of the study parts also have other objectives to learn about the safety, tolerability, concentration of KPL-387 in blood, and effects of KPL-387 on blood test markers of immune activity in recurrent pericarditis.

PericarditisPericarditis AcuteRecurrent Pericarditis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • 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

including positive

What the study is looking for

  • ✓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)

Who cannot take part

  • ✗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...
  • ✗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.
See the full 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.

Where Is This Study? (4 UK sites)

Investigational Site 020

London EC1A 7BE, United Kingdom

Recruiting

Investigational Site 047

London NW3 2QG, United Kingdom

Recruiting

Investigational Site 035

London SE1 7EH, United Kingdom

Recruiting

Investigational Site 017

Southampton SO17 1BJ, 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: 2026-07