Transition to KPL-387 Monotherapy Dosing & Administration Study

Summary

The primary objective of this study is to characterize the efficacy and safety of dosing regimens used to transition from prior pericarditis therapies to KPL-387 monotherapy in participants with well-controlled recurrent pericarditis on standard therapies.

Eligibility

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.

Conditions4

Locations6 sites

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