Phase 2/3 Study of KPL-387 in Recurrent Pericarditis

Launched by KINIKSA PHARMACEUTICALS INTERNATIONAL, PLC · May 29, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment called KPL-387 for people who have recurrent pericarditis, which is a condition where the lining around the heart becomes inflamed repeatedly. The goal of the study is to see if KPL-387 is both safe and effective for treating this condition, especially in patients who haven't had relief from standard treatments like NSAIDs (anti-inflammatory medications) or colchicine.

To participate in this trial, individuals need to be between 18 and 75 years old and have been diagnosed with recurrent pericarditis that hasn’t improved with existing treatments. They should weigh at least 40 kg (about 88 pounds) and should currently be taking NSAIDs and/or colchicine. However, there are some restrictions, such as having certain infections or medical conditions that could affect the study. Participants will receive the new treatment and will be monitored closely throughout the study to track their progress and any side effects. This trial is not yet recruiting, so there’s still time to learn more if you think you might be eligible.

Gender

ALL

Eligibility criteria

• 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.