KPL-387単剤投与への移行：投与量・投与方法に関する研究
標準療法からKPL-387単剤療法への移行レジメンの有効性と安全性を評価する、再発性心膜炎が良好にコントロールされている参加者を対象とした長期延長を伴う第2相用量設定試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Project Manager
- 電話番号：781-431-9100
- メール：clinicaltrials@kiniksa.com
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85054
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- Investigational Site 031
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California
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La Jolla、California、アメリカ、92037
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- Investigational Site 045
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Los Angeles、California、アメリカ、90048
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- Investigational Site 014
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Santa Monica、California、アメリカ、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、アメリカ、20010
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- Investigational Site 046
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Florida
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Jacksonville、Florida、アメリカ、32224
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- Investigational Site 039
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Illinois
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Chicago、Illinois、アメリカ、60611
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- Investigational Site 013
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Maryland
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Baltimore、Maryland、アメリカ、21287
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- Investigational Site 025
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Massachusetts
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Boston、Massachusetts、アメリカ、02199
- 募集
- Investigational Site 043
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- 募集
- Investigational Site 028
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Missouri
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St Louis、Missouri、アメリカ、63130
- 募集
- Investigational Site 042
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New York
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New York、New York、アメリカ、10016
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- Investigational Site 011
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New York、New York、アメリカ、10032
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- Investigational Site 003
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Ohio
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Cincinnati、Ohio、アメリカ、45219
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- Investigational Site 009
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Cleveland、Ohio、アメリカ、44195
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- Investigational Site 040
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Texas
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Austin、Texas、アメリカ、78705
- 募集
- Investigational Site 005
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Dallas、Texas、アメリカ、75235
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- Investigational Site 047
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Houston、Texas、アメリカ、77030
- 募集
- Investigational Site 006
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Virginia
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Charlottesville、Virginia、アメリカ、22903
- 募集
- Investigational Site 004
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Norfolk、Virginia、アメリカ、23507
- 募集
- Investigational Site 001
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Richmond、Virginia、アメリカ、23284
- 募集
- Investigational Site 008
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London、イギリス、EC1A 7BE
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- Investigational Site 012
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London、イギリス、SE1 7EH
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- Investigational Site 007
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London、イギリス、NW3 2QG
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- Investigational Site 022
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Florence、イタリア、50134
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- Investigational Site 044
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Genoa、イタリア、16147
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- Investigational Site 034
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Milan、イタリア、20157
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- Investigational Site 021
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Padua、イタリア、35143
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- Investigational Site 036
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Udine、イタリア、33100
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- Investigational Site 033
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Varese、イタリア、21100
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- Investigational Site 037
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Ontario
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Ottawa、Ontario、カナダ、K1N 6N5
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- Investigational Site 010
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Athens、ギリシャ、115 28
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- Investigational Site 035
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Nea Ionia、ギリシャ、142 33
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- Investigational Site 023
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Voula、ギリシャ、166 73
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- Investigational Site 024
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Barcelona、スペイン、08017
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- Investigational Site 019
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Barcelona、スペイン、08035
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- Investigational Site 015
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Madrid、スペイン、28034
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- Investigational Site 017
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Madrid、スペイン、28850
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- Investigational Site 016
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Valencia、スペイン、46015
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- Investigational Site 018
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Belgrade、セルビア、1100
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- Investigational Site 030
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Belgrade、セルビア、11040
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- Investigational Site 029
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Dresden、ドイツ、01307
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- Investigational Site 041
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Paris、フランス、75013
- 募集
- Investigational Site 027
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Poitiers、フランス、86000
- 募集
- Investigational Site 026
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Toulouse、フランス、31400
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- Investigational Site 038
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Toulouse、フランス、31400
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- Investigational Site 032
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Warsaw、ポーランド、02-507
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- Investigational Site 020
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Warsaw、ポーランド、02-097
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- Investigational Site 048
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Posology KPL-387
In Posology Study, KPL-387 will be administered by subcutaneous (SC) injection through Week 16. |
administered by subcutaneous injection |
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
長期延長試験：LTE終了までの心膜炎再発の年間発生率。
時間枠：最長24ヶ月
|
最長24ヶ月
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Posology: Proportion of participants free from Pericarditis Recurrence by Week 16
時間枠：From baseline up to Week 16
|
From baseline up to Week 16
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Posology: Time to Pericarditis Recurrence by Week 16
時間枠：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
時間枠：Up to 24 Months
|
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
時間枠：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
|
|
Long Term Extension: Change from LTE Baseline in EQ-5D-5L individual index scores over time through the end of the LTE
時間枠：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
|
|
Long Term Extension: Change from LTE Baseline in EQ-5D-5L visual analog scale (VAS) over time through the end of the LTE.
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。