VIS954 for Treating Inflammatory Skin Problems
A Phase 2a, Multicenter, Basket Study of VIS954 in Participants With Inflammatory Skin Diseases
This is a phase 2, multicenter, basket study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VIS954 in adults with inflammatory skin diseases (ISDs).
調査の概要
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：Otsuka Call Center
- 電話番号：844-687-8522
- メール：otsuka-professionalservices@otsuka-us.com
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
- Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
- HS- Adults with moderate-to-severe HS of at least 6 months' duration, classified as Hurley Stage II or III, with an inadequate response, intolerance, or contraindication to prior standard systemic antibiotic therapy.
- PG-Adults with clinically confirmed moderate-to-severe ulcerative PG requiring systemic therapy and presenting with at least one active ulcerative lesion of less than 6 months' duration.
- BP-Adults with newly diagnosed or relapsing classical BP, confirmed by clinical presentation and direct immunofluorescence and/or BP180/BP230 serology, with moderate disease activity.
Key Exclusion Criteria
- Participants cannot join the study if they have another active skin condition, medical condition, or mental health condition that, in the study doctor's opinion, could affect the study results, increase safety risks, require restricted medications during the study, or make participation unsuitable.
- HS-Lack of adequate response, as determined by the investigator.
- PG-Presence of active infection involving the target ulcer or non-PG mimics that may interfere with assessment of pyoderma gangrenosum disease activity or treatment response.
- BP- Participants with any pemphigoid disease other than classic BP, BP secondary to medications, or any severe comorbid illness.
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HS Cohort: VIS954
Participants with Hidradenitis Suppurativa (HS) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
プラセボコンパレーター：HS Cohort: Placebo
Participants with HS will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
実験的：PG Cohort: VIS954
Participants with Pyoderma Gangrenosum (PG) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
プラセボコンパレーター：PG Cohort: Placebo
Participants with PG will receive placebo in the placebo-controlled period. |
VIS954-matching placebo solution for injection |
|
実験的：BP Cohort: VIS954
Participants with Bullous Pemphigoid (BP) will receive VIS954 during the placebo-controlled and treatment period. |
VIS954 solution for injection |
|
プラセボコンパレーター：BP Cohort: Placebo
Participants with BP received placebo in the placebo-controlled period. |
VIS954-matching placebo solution for 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 |
|---|---|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Adverse Events (AEs) and AEs Related to Infection
時間枠：Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Laboratory Abnormalities' Events
時間枠：Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Vital Signs' Events
時間枠：Up to Week 36
|
Up to Week 36
|
|
HS, PG, and BP Cohorts: Incidence Assessed as Number of Clinically Significant Physical Examination Events
時間枠：Up to Week 36
|
Up to Week 36
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
HS, PG, and BP Cohorts: C5aR1 Percentage Receptor Occupancy on Circulating Neutrophils
時間枠：Predose and at multiple timepoints postdose up to Day 225
|
Predose and at multiple timepoints postdose up to Day 225
|
|
HS, PG, and BP Cohorts: Maximum Plasma Concentration (Cmax) of VIS954
時間枠：Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Time to Reach Maximum Plasma Concentration (tmax) of VIS954
時間枠：Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUCtau)
時間枠：Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Terminal Elimination Half-life (t1/2z)
時間枠：Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Clearance (CL/F)
時間枠：Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
|
HS, PG, and BP Cohorts: Apparent Volume of Distribution (Vz/F)
時間枠：Predose and at multiple timepoints postdose up to Day 253
|
Predose and at multiple timepoints postdose up to Day 253
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
その他の研究ID番号
- 381-201-00028
- 2026-525969-41-00 (Ctis)
- 1014049 (その他の識別子：Integrated Research Application System (IRAS))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD 共有時間枠
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD 共有アクセス基準
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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