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

A Phase 2 Posology Study With Long-Term Extension in Participants With Well-Controlled Recurrent Pericarditis to Evaluate the Efficacy and Safety of Transition Regimens to KPL-387 Monotherapy From Standard Therapies

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.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Kiniksa Pharmaceuticals International, plc (Industry-sponsored)
• Locations: 14 sites (Los Angeles, California and 13 other locations)
• Trial ID: NCT07288216 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with well-controlled recurrent pericarditis on a stable regimen for at least 3 months, with baseline CRP < 0.5 mg/dL and pericarditis pain NRS ≤ 3, and a prior documented CRP elevation > 1 mg/dL during an earlier episode.

Not a fit: Patients with a pericarditis recurrence within the prior 3 months, pericarditis from excluded secondary causes, uncontrolled inflammation, recent investigational drug use, or other disqualifying conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, KPL-387 could offer a single-drug option to maintain remission and reduce reliance on multiple pericarditis medications.

How similar studies have performed: Other IL-1 pathway inhibitors such as rilonacept and anakinra have shown benefit in recurrent pericarditis, but using KPL-387 specifically for structured transition to monotherapy is a novel application.

Eligibility 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 this trial is running

Los Angeles, California and 13 other locations

• Investigational Site 014 — Los Angeles, California, United States (Recruiting)
• Investigational Site 002 — Santa Monica, California, United States (Recruiting)
• Investigational Site 013 — Chicago, Illinois, United States (Recruiting)
• Investigational Site 011 — New York, New York, United States (Recruiting)
• Investigational Site 003 — New York, New York, United States (Recruiting)
• Investigational Site 009 — Cincinnati, Ohio, United States (Recruiting)
• Investigational Site 005 — Austin, Texas, United States (Recruiting)
• Investigational Site 006 — Houston, Texas, United States (Recruiting)
• Investigational Site 004 — Charlottesville, Virginia, United States (Recruiting)
• Investigational Site 001 — Norfolk, Virginia, United States (Recruiting)
• Investigational Site 008 — Richmond, Virginia, United States (Recruiting)
• Investigational Site 010 — Ottawa, Ontario, Canada (Recruiting)
• Investigational Site 012 — London, United Kingdom (Recruiting)
• Investigational Site 007 — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Clinical Project Manager

Conditions Recurrent Pericarditis; Heart Diseases; Pericarditis; Recurrence; Recurrent; KPL-387