NCT06431373进行中（未招募）3 期
A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 371
- 试验地点
- 107
- 主要终点
- Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18-75 years old)
- •Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
- •Active uveitic disease in at least 1 eye
- •Weight > 40 kg with a body mass index ≤ 40 kg/m2
排除标准
- •Has confirmed or suspected current diagnosis of infectious uveitis 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 disease within the last 12 months
- •a high risk for herpes zoster reactivation
- •active or recent infections
研究组 & 干预措施
Arm 1
Experimental
干预措施: Brepocitinib PO QD (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo PO QD (Drug)
结局指标
主要结局
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48
时间窗: 48 weeks
次要结局
- Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24(24 weeks)
- Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24(24 weeks)
- Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24(24 weeks)
- Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48(48 Weeks)
- Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48(48 weeks)
研究者
Clinical Trial Administrator
Scientific
Priovant Therapeutics Inc.
研究点 (107)
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相关资讯
Priovant Eyes Broad Autoimmune Applications for Brepocitinib After Promising Phase II Results- Priovant Therapeutics is considering expanding the development of brepocitinib to multiple autoimmune indications based on Phase II trial results.
- Brepocitinib, a dual TYK2/JAK1 inhibitor, has demonstrated efficacy in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
- Phase III trials are ongoing for dermatomyositis (VALOR trial) and non-anterior non-infectious uveitis (CLARITY trial), with topline data expected in 2025.
- The FDA granted Fast Track designation to brepocitinib for non-infectious uveitis following positive Phase II NEPTUNE trial data.last yearBrepocitinib Shows Promise in Non-Infectious Uveitis: Phase 3 Trial Initiated- Priovant Therapeutics' brepocitinib demonstrated significant treatment failure reductions in the Phase 2 NEPTUNE trial for non-infectious uveitis.
- The CLARITY Phase 3 trial has been initiated to further evaluate brepocitinib's efficacy against non-anterior non-infectious uveitis, comparing 45mg dose to placebo.
- Brepocitinib received Fast Track Designation from the FDA, expediting its development for non-infectious uveitis due to unmet medical needs.
- The dual TYK2/JAK1 inhibitor showed a dose-dependent improvement in retinal vascular leakage, as measured by fluorescein angiography, in the NEPTUNE trial.last year