計劃書編號PVT-2201-303
試驗執行中
2024-12-01 - 2028-02-01
Phase III
召募中4
ICD-10H44.111
右側眼全葡萄膜炎
ICD-10H44.112
左側眼全葡萄膜炎
ICD-10H44.113
雙側全葡萄膜炎
ICD-10H44.119
未明示側性全葡萄膜炎
ICD-9360.12
全葡萄膜炎
一項第 3 期、隨機分配、雙掩蓋、安慰劑對照試驗，研究口服 Brepocitinib 用於活動性、非感染性中段、後段和全葡萄膜炎成人患者的安全性和療效
-
試驗申請者
保瑞爾生技股份有限公司
-
試驗委託 / 贊助單位名稱
保瑞爾生技股份有限公司
-
臨床試驗規模
多國多中心
-
更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
治療成人活動性、非感染性中段、後段和全葡萄膜炎
試驗目的
Primary:
•To evaluate the efficacy of brepocitinib in participants with noninfectious intermediate uveitis, posterior uveitis, and panuveitis
Secondary:
•To further evaluate the efficacy of brepocitinib in participants with noninfectious intermediate uveitis, posterior uveitis, and panuveitis
•To evaluate the safety and tolerability of brepocitinib in participants with noninfectious intermediate uveitis, posterior uveitis, and panuveitis
藥品名稱
錠劑
錠劑
錠劑
錠劑
錠劑
錠劑
錠劑
錠劑
錠劑
主成份
Brepocitinib
6804001800
6804001800
劑型
110
110
110
110
110
110
110
110
110
劑量
45mg/tablet or 0mg/tablet
45mg/tablet
5mg/tablet
10mg/tablet
20mg/tablet
45mg/tablet
5mg/tablet
10mg/tablet
20mg/tablet
評估指標
在第 1 期第 6 週或之後直至第 1 期第 48 週期間的治療失敗前所經時間
主要納入條件
1. Adult subjects (18-75 years old)
2.Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
3.Active uveitic disease in at least 1 eye.Weight > 40 kg with a body mass index (< or = 40) kg/m2.
2.Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
3.Active uveitic disease in at least 1 eye.Weight > 40 kg with a body mass index (< or = 40) kg/m2.
主要排除條件
1.Has confirmed or suspected current diagnosis of infectious uveitis
2.History of or have:
•Lymphoproliferative disorder
•active malignancy;
•cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.
•thrombosis or cerebrovascular ischemic event within the last 12 months
•a high risk for herpes zoster reactivation
•active or recent infections
2.History of or have:
•Lymphoproliferative disorder
•active malignancy;
•cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.
•thrombosis or cerebrovascular ischemic event within the last 12 months
•a high risk for herpes zoster reactivation
•active or recent infections
試驗計畫預計收納受試者人數
-
台灣人數
20 人
-
全球人數
340 人
