KPL-387 for recurrent pericarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 interventional trial enrolls participants with recurrent pericarditis who are experiencing an acute flare and assigns them to KPL-387 or placebo to determine the best dose and confirm effectiveness. Phase 2 compares different dosing regimens to identify the regimen taken forward, Phase 3 confirms efficacy for symptom control and reduction in recurrence risk, and an optional long-term extension follows participants to monitor durability of disease control. Safety, tolerability, blood drug concentrations, and blood markers of immune activity are measured throughout. Background therapy such as NSAIDs and colchicine (and glucocorticoids in Phase 3) is permitted per the protocol.

Why it matters

Who can join: the full rules

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 it's running

• Investigational Site 018
  Gilbert, Arizona, United States Recruiting
• Investigational Site 053
  Phoenix, Arizona, United States Recruiting
• Investigational Site 064
  La Jolla, California, United States Recruiting
• Investigational Site 030
  Los Angeles, California, United States Recruiting
• Investigational Site 008
  San Francisco, California, United States Recruiting
• Investigational Site 044
  Santa Monica, California, United States Recruiting

+17 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Project Manager
• Email: clinicaltrials@kiniksa.com
• Phone: 781-431-9100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transitioning people with recurrent pericarditis to KPL-387 monotherapy dosing and administration

  This trial will try switching people with well-controlled recurrent pericarditis from their current therapies to KPL-387 alone for up to 16 weeks to see if symptoms and inflammation stay controlled and the drug is tolerable.

  Recruiting at 48 sites Phase 2 Kiniksa Pharmaceuticals International, plc · Phoenix, Arizona and 47 other locations · NCT07288216

• National surveillance of myocarditis and pericarditis after mRNA COVID-19 vaccination

  This study is trying to see how mRNA COVID-19 vaccines might affect heart health by following patients who develop heart inflammation after getting vaccinated.

  Recruiting Cardiology Research UBC · Vancouver, British Columbia · NCT06103123

• Heart@Home: Safe, at-home care for people with acute heart problems compared with hospital care

  This trial tests whether hospital-level care at home can safely and effectively treat adults with acute heart conditions who would normally be in the hospital.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07913152

• Camptodactyly–Arthropathy–Coxa Vara–Pericarditis (CACP) syndrome patient registry and genetic review

  This registry collects clinical and genetic information to better understand CACP syndrome in children with confirmed PRG4 mutations.

  Recruiting at 3 sites Meyer Children's Hospital IRCCS · Bari and 9 other locations · NCT07468461

• Pericardial inflammation imaging to predict recurrent pericarditis

  Doctors are testing imaging tools to see if FDG PET/CT and MRI can predict which patients with recurrent pericarditis will flare again.

  Recruiting Phase 3 Ottawa Heart Institute Research Corporation · Ottawa, Ontario · NCT07245849

• Imaging in Inflammatory Heart Diseases linked to autoimmune disorders

  This study tests how well multimodality imaging (CMR, echocardiography, and PET) detects inflammation in people with suspected inflammatory heart or autoimmune rheumatic diseases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07077304

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.