A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 24
- 主要终点
- Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
- •Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:
- •Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
- •≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria
- •≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria
- •No evidence of active tuberculosis (TB) or untreated latent TB
排除标准
- •Participants with elevated intraocular pressures and/or severe glaucoma
- •Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
- •Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Filgotinib
Participants will receive filgotinib 200 milligrams (mg) once daily for up to 52 weeks along with a standardized prednisone burst of 60 milligrams per day (mg/day) at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
干预措施: Filgotinib (Drug)
Filgotinib
Participants will receive filgotinib 200 milligrams (mg) once daily for up to 52 weeks along with a standardized prednisone burst of 60 milligrams per day (mg/day) at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
干预措施: Prednisone (Drug)
Placebo
Participants will receive placebo to match filgotinib once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
干预措施: Placebo to match filgotinib (Drug)
Placebo
Participants will receive placebo to match filgotinib once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
干预措施: Prednisone (Drug)
结局指标
主要结局
Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
时间窗: Week 6 through Week 24
Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Week (Wk) 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in Anterior Chamber (AC) cell grade (Standardization of Uveitis Nomenclature \[SUN\] criteria)\[AC cell grades range from 0 (0 cells) to 4+ (\>50 cells), higher scores=severe uveitis\]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in Vitreous Haze (VH) grade (National Eye Institute \[NEI\]/SUN criteria)\[VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis\]; Worsening of best corrected visual acuity (BCVA) by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis.
次要结局
- Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET)(Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks))
- Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET(Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks))
- Time to Treatment Failure on or After Week 6(Week 6 through Week 52)
- Plasma Concentration of Metabolite, GS-829845(Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time)
- Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET(Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks))
- Time to Development of Macular Edema in At Least One Eye on or After Week 6(Week 6 through Week 52)
- Plasma Concentration of Filgotinib(Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time)
- Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET(Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks))