KPL-387 Treatment in Participants With Recurrent Pericarditis

What is the Purpose of this Study?

The purpose of this study is to determine whether KPL-387 is an effective and safe treatment in patients with recurrent pericarditis. Pericarditis is a condition in which the thin layers of tissue that surrounds the heart become inflamed or swollen, often leading to chest pain. KPL-387 is a monoclonal antibody (protein made in a laboratory). Monoclonal antibodies can bind to and block specific activities of human cells that contribute to disease. KPL-387 is designed to block the IL-1 receptor on human cells. The activity of this receptor has been shown to contribute to inflammation of the pericardium. Researchers will evaluate whether blocking IL-1 with KPL-387 can reduce signs of inflammation and the pain that it causes.

Eligibility

* 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)

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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Phase 2/3 Efficacy and Safety Study of KPL-387 Treatment in Participants with Recurrent Pericarditis

Study Details

Disease Type/Condition

Other

Principal Investigator

Marano, Paul

Age Group

Adult

Phase

II/III

IRB Number

STUDY00004273

ClinicalTrials.gov ID

NCT07010159

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org