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

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 open-label Phase 2 posology study enrolls participants with well-controlled recurrent pericarditis who are on stable standard therapies or IL-1 pathway inhibitors and transitions them to KPL-387 monotherapy per protocol for up to 16 weeks. Participants will have regular visits to record pericarditis pain numerical rating scale (NRS) scores, physical exam findings, CRP levels, safety assessments, and pharmacokinetic sampling. Those with new or worsening pericarditis symptoms will be managed according to protocol-defined procedures. After the Week 16 visit, eligible participants may enter an open-label long-term extension to continue monitoring efficacy and safety.

Why it matters

Who can join: the full rules

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 it's running

• Investigational Site 031
  Phoenix, Arizona, United States Recruiting
• Investigational Site 045
  La Jolla, California, United States Recruiting
• Investigational Site 014
  Los Angeles, California, United States Recruiting
• Investigational Site 002
  Santa Monica, California, United States Recruiting
• Investigational Site 046
  Washington D.C., District of Columbia, United States Recruiting
• Investigational Site 039
  Jacksonville, Florida, United States Recruiting

Study contacts

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

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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.