NCT05523765已完成2 期
A Phase 2 Randomized, Double-Masked, Dose-Ranging 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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active 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
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18-74 years old)
- •Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
- •Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator:
- •Active, inflammatory chorioretinal and/or retinal vascular lesion; OR
- •≥2+ vitreous haze grade (NEI/SUN criteria).
- •Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
- •Weight > 40 kg with a body mass index < 40 kg/m2.
排除标准
- •Has isolated anterior uveitis.
- •Has confirmed or suspected current diagnosis of infectious uveitis
- •History of:
- •Any lymphoproliferative disorder
- •Active malignancy;
- •History of 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.)
- •At risk of thrombosis and cardiovascular disease
- •Have a high risk for herpes zoster reactivation
- •Have active or recent infections
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Brepocitinib Dose Level 1 by mouth (PO) once daily (QD)
Experimental
干预措施: Brepocitinib (Drug)
Brepocitinib Dose Level 2 by mouth (PO) once daily (QD)
Experimental
干预措施: Brepocitinib (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Screening up to 28 days after the last dose of study drug at 52 weeks
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful.
次要结局
- Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24(24 weeks)
研究者
研究点 (1)
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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