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.
How this trial compares with your answers
Answer 2 more questions to improve match
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
- ✓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
Where Is This Study? (4 UK sites)
Investigational Site 020
London EC1A 7BE, United Kingdom
Investigational Site 047
London NW3 2QG, United Kingdom
Investigational Site 035
London SE1 7EH, United Kingdom
Investigational Site 017
Southampton SO17 1BJ, United Kingdom
How to Get in Touch
Clinical Project Manager
Sponsor contactCONTACT
