[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kiniksa Pharmaceuticals International, plc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100615100","phase-2-transition-to-kpl-387-monotherapy-dosing--administration-study-100615100",false,"NCT07288216","Transition to KPL-387 Monotherapy Dosing & Administration Study","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","Key Inclusion Criteria:\n\n* Has well-controlled recurrent pericarditis (i.e., including having CRP \\\u003C 0.5 mg\u002FdL within 14 days of Baseline and a pericarditis pain NRS score ≤ 3 at Baseline)\n* Has a documented history of CRP elevation (\\> 1 mg\u002FdL) associated with at least one prior acute pericarditis episode, whether the incident event or any pericarditis recurrence\n* 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\u002For colchicine, and\u002For glucocorticoids or an IL-1 pathway inhibitor (anakinra or rilonacept).\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies\n* Has had a pericarditis recurrence in the last 3 months prior to Baseline\n* 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.\n* Has a history of active or untreated, latent tuberculosis (TB) prior to screening.\n* Has a history of immunodeficiency.\n* Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.\n* 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.\n* 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\u002For localized carcinoma in situ of the cervix).\n* 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\u002Fsoft tissue infection.\n* 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.\n* Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).\n* In the Investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.","ALL","18 Years","80 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28,29],"Recurrent Pericarditis","Heart Diseases","Pericarditis",[31,32,33,27],"Recurrence","Recurrent","KPL-387","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2026-03-25",{"date":42,"type":21},"2029-12-31",{"name":44,"class":45},"Kiniksa Pharmaceuticals International, plc","INDUSTRY",33,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":69},"100593724","phase-2-phase-23-study-of-kpl-387-in-recurrent-pericarditis-100593724","NCT07010159","Phase 2\u002F3 Study of KPL-387 in Recurrent Pericarditis","A Phase 2\u002F3 Efficacy and Safety Study of KPL-387 Treatment in Participants With Recurrent Pericarditis","Key Inclusion Criteria:\n\n* Phase 2 and 3: Has a diagnosis of recurrent pericarditis\n* Phase 2 and 3: Has signs and symptoms of recurrent pericarditis despite treatment with standard therapies\n* Phase 2 and 3: Weighs at least 40 kg\n* Phase 2: Taking NSAIDS and\u002For colchicine (in any combination)\n* Phase 3: Taking NSAIDs and\u002For colchicine and\u002For glucocorticoids (in any combination)\n\nKey Exclusion Criteria:\n\n* Phase 2 and 3: Has a diagnosis of pericarditis that is secondary to specific prohibited etiologies.\n* 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.\n* Phase 2 and 3: Has a history of active or untreated, latent tuberculosis (TB) prior to screening.\n* Phase 2 and 3: Has a history of immunodeficiency.\n* Phase 2 and 3: Has a history of immunosuppression, including positive human immunodeficiency virus (HIV) test results.\n* 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.\n* 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\u002For localized carcinoma in situ of the cervix).\n* 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\u002Fsoft tissue infection.\n* 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.\n* Phase 2 and 3: Has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration).\n* 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.",{"count":55,"type":21},165,[24,57],"PHASE3","This study is being done to demonstrate whether KPL-387 is an effective and safe treatment for recurrent pericarditis.",[29,60,27],"Pericarditis Acute",[31,32,27,33],"2026-06-04",{"date":64,"type":38},"2026-06-08",{"date":66,"type":38},"2025-07-25",{"date":42,"type":21},{"name":44,"class":45},58,""]