KPL-387 단일 요법 투여 및 투여 연구로의 전환
표준 요법에서 KPL-387 단일 요법으로의 전환 요법의 효능과 안전성을 평가하기 위한 잘 조절된 재발성 심낭염 참가자를 대상으로 한 장기 연장을 포함한 2상 투약량 연구
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.
연구 개요
상세 설명
During the Posology (Dosing and Administration) Study, participants on oral pericarditis therapies alone (i.e., non-steroidal anti-inflammatory drugs [NSAIDs], colchicine, and/or glucocorticoids) and participants on Interleukin-1 (IL-1) pathway inhibition drugs will transition to KPL-387 per protocol guidelines. Participants will receive KPL-387 for up to 16 weeks in the Posology Study.
At study visits throughout the Posology Study, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain numerical rating scale [NRS] scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., C-reactive protein [CRP]) as well as treatment tolerability and pharmacokinetics (PK). Participants experiencing new or worsening symptoms consistent with pericarditis will be managed per study protocol.
All active, enrolled participants in the Posology Study who have not completed an End of Treatment (EOT) Visit may be eligible to transition into the Long-Term Extension (LTE) following completion of the Week 16 Visit. The Week 16 Visit will serve as both a Posology Study End of Study Visit and a Baseline Visit for the LTE. Participants who choose not to participate in the LTE will complete an EOT Visit followed by a Safety Follow-Up until 8 weeks after the last KPL-387 dose administration.
The open-label LTE is designed to evaluate the long-term efficacy and safety of KPL-387 in recurrent pericarditis (RP). Treatment in the LTE may continue until the participant has received up to 24 months of treatment in the LTE or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first.
At study visits throughout the LTE, participants will be queried for symptoms of chest pain (and participants will fill out pericarditis pain NRS scores) and will be assessed for physical signs (e.g., pericardial friction rub) and laboratory evidence of pericarditis activity (e.g., CRP) as well as treatment tolerability and PK. Participants experiencing new or worsening symptoms consistent with pericarditis will be managed as described in the protocol.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Clinical Project Manager
- 전화번호: 781-431-9100
- 이메일: clinicaltrials@kiniksa.com
연구 장소
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Athens, 그리스, 115 28
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- Investigational Site 035
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Nea Ionia, 그리스, 142 33
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- Investigational Site 023
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Voula, 그리스, 166 73
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- Investigational Site 024
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Dresden, 독일, 01307
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- Investigational Site 041
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Arizona
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Phoenix, Arizona, 미국, 85054
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- Investigational Site 031
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California
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La Jolla, California, 미국, 92037
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- Investigational Site 045
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Los Angeles, California, 미국, 90048
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- Investigational Site 014
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Santa Monica, California, 미국, 90404
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- Investigational Site 002
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
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- Investigational Site 046
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Florida
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Jacksonville, Florida, 미국, 32224
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- Investigational Site 039
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Illinois
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Chicago, Illinois, 미국, 60611
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- Investigational Site 013
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Maryland
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Baltimore, Maryland, 미국, 21287
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- Investigational Site 025
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Massachusetts
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Boston, Massachusetts, 미국, 02199
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- Investigational Site 043
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Minnesota
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Rochester, Minnesota, 미국, 55905
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- Investigational Site 028
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Missouri
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St Louis, Missouri, 미국, 63130
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- Investigational Site 042
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New York
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New York, New York, 미국, 10016
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- Investigational Site 011
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New York, New York, 미국, 10032
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- Investigational Site 003
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Ohio
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Cincinnati, Ohio, 미국, 45219
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- Investigational Site 009
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Cleveland, Ohio, 미국, 44195
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- Investigational Site 040
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Texas
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Austin, Texas, 미국, 78705
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- Investigational Site 005
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Dallas, Texas, 미국, 75235
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- Investigational Site 047
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Houston, Texas, 미국, 77030
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- Investigational Site 006
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Virginia
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Charlottesville, Virginia, 미국, 22903
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- Investigational Site 004
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Norfolk, Virginia, 미국, 23507
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- Investigational Site 001
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Richmond, Virginia, 미국, 23284
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- Investigational Site 008
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Belgrade, 세르비아, 1100
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- Investigational Site 030
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Belgrade, 세르비아, 11040
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- Investigational Site 029
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Barcelona, 스페인, 08017
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- Investigational Site 019
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Barcelona, 스페인, 08035
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- Investigational Site 015
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Madrid, 스페인, 28034
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- Investigational Site 017
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Madrid, 스페인, 28850
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- Investigational Site 016
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Valencia, 스페인, 46015
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- Investigational Site 018
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London, 영국, EC1A 7BE
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- Investigational Site 012
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London, 영국, SE1 7EH
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- Investigational Site 007
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London, 영국, NW3 2QG
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- Investigational Site 022
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Florence, 이탈리아, 50134
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- Investigational Site 044
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Genoa, 이탈리아, 16147
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- Investigational Site 034
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Milan, 이탈리아, 20157
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- Investigational Site 021
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Padua, 이탈리아, 35143
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- Investigational Site 036
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Udine, 이탈리아, 33100
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- Investigational Site 033
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Varese, 이탈리아, 21100
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- Investigational Site 037
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Ontario
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Ottawa, Ontario, 캐나다, K1N 6N5
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- Investigational Site 010
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Warsaw, 폴란드, 02-507
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- Investigational Site 020
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Warsaw, 폴란드, 02-097
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- Investigational Site 048
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Paris, 프랑스, 75013
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- Investigational Site 027
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Poitiers, 프랑스, 86000
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- Investigational Site 026
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Toulouse, 프랑스, 31400
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- Investigational Site 038
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Toulouse, 프랑스, 31400
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- Investigational Site 032
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Posology KPL-387
In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16. |
administered by subcutaneous injection |
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실험적: Long-Term Extension
Participants from Posology Study who continue into the Long-Term Extension will receive KPL-387 for up to 24 months or until KPL-387 is approved for commercial use in that region to treat pericarditis, whichever occurs first. |
administered by subcutaneous injection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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장기 연장 연구: LTE 종료 시까지 심낭염 재발의 연간 발생률.
기간: 최대 24개월
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최대 24개월
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Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
기간: From baseline up to Week 16
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From baseline up to Week 16
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Posology: Time to Pericarditis Recurrence by Week 16
기간: From baseline up to Week 16
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From baseline up to Week 16
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Long Term Extension: Change from LTE Baseline in SF-36v2 Physical Component Summary score through the end of the LTE
기간: Up to 24 Months
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SF-36 (36-item Short Form Survey) Physical Component determines participants' quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement. |
Up to 24 Months
|
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Long Term Extension: Change from LTE Baseline in SF-36v2 Mental Component Summary score through the end of the LTE
기간: Up to 24 Months
|
SF-36 (36-item Short Form Survey) Mental Component determines participants' quality of life by assessing 1) vitality; 2) limitations in social functioning because of physical or emotional problems; 3) limitations in usual role due to emotional problems; and 4) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best) with higher scores indicating better health. Increases from baseline indicate improvement. |
Up to 24 Months
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Long Term Extension: Change from LTE Baseline in EQ-5D-5L individual index scores over time through the end of the LTE
기간: Up to 24 months
|
The EQ-5D-5L (EuroQol-5 Dimension 5-level) is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Individual and index scores range from 0 to 1, with low scores representing a higher level of dysfunction. |
Up to 24 months
|
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Long Term Extension: Change from LTE Baseline in EQ-5D-5L visual analog scale (VAS) over time through the end of the LTE.
기간: Up to 24 months
|
The EQ-5D-5L (EuroQol-5 Dimension 5-level) is a self-reported health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are 2 components to the EQ-5D-5L: a 5-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a VAS that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. |
Up to 24 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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