NCT05384249终止2 期
A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Non-infectious, Intermediate-, Posterior- or Pan-uveitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Time to treatment failure defined as reaching treatment failure by meeting ≥ 1 of the 4 criteria specified in the protocol in at least 1 eye.
研究概览
简要总结
Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •18 years to 75 years of age
- •Type of Subject and Disease Characteristics
- •Subject is diagnosed with non-infectious intermediate-, posterior- or pan-uveitis
- •Active disease defined by the presence of at least 1 of the following criteria in at least 1 eye despite treatment with stable doses of corticosteroids for at least 2 weeks prior to day 1:
- •Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy, fundus photography, fluorescein angiography (FA), and Spectral-Domain Optical Coherence Tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reading center assessment using FA, fundus photography and/or SD-OCT is required to confirm eligibility prior to day 1).
- •≥ 2+ vitreous haze (National Eye Institute [NEI]/Standardization of Uveitis Nomenclature [SUN] criteria) by digital indirect ophthalmoscope and fundus photography (the central reading center assessment using fundus photography is required to confirm eligibility prior to day 1).
- •Currently receiving treatment with oral corticosteroids (≥ 7.5 mg/day to ≤ 40 mg/day oral prednisone/prednisolone or corticosteroid equivalent) at a stable dose for at least 2 weeks prior to day 1.
排除标准
- •Disease-related Medical Conditions
- •Subject with isolated anterior uveitis
- •Subject with serpiginous choroidopathy
- •Subject with confirmed or suspected infectious uveitis
- •Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the study
- •Subject with intraocular pressure of ≥ 25 mmHg while on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury
- •Subject with severe vitreous haze that precludes visualization of the fundus prior to first dose of study drug
- •Subject has a contraindication for mydriatic eye drops OR subject cannot be dilated sufficiently well to permit good fundus visualization
- •Subject with best corrected visual acuity (BCVA) < 20 letters (Early Treatment Diabetic Retinopathy Study [ETDRS]) in at least 1 eye prior to first dose of study drug
- •Subject with proliferative or severe non-proliferative retinopathy or clinically significant macular edema due to diabetic retinopathy
- •Subject with neovascular/wet age-related macular degeneration
- •Subject with an abnormality of the vitreo-retinal interface with the potential for macular structural damage independent of the inflammatory process
- •Subject with a history of active scleritis ≤ 12 months of first dose of study drug
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Group 1: Placebo subcutaneous once weekly
Placebo Comparator
Participants will receive placebo every week to week 51.
干预措施: Placebo (Drug)
Group 2: Izokibep subcutaneous once weekly
Experimental
Participants will receive izokibep every week to week 51.
干预措施: Izokibep (Drug)
结局指标
主要结局
Time to treatment failure defined as reaching treatment failure by meeting ≥ 1 of the 4 criteria specified in the protocol in at least 1 eye.
时间窗: Up to Week 52
次要结局
- Change in best corrected visual acuity (BCVA) from best state achieved(Before Week 10 to Week 24)
- Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved(Before Week 10 to Week 24)
- Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT)(Baseline to Week 10)
- Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved(Week 10 up to Week 52)
- Proportion of subjects that achieve quiescence(Week 10)
- Incidence of treatment-emergent adverse events (TEAEs)(Baseline up to Follow-up (Week 65))
- Incidence of serious adverse events (SAEs)(Baseline up to Follow-up (Week 65))
- Incidence of clinically significant changes in vital signs(Baseline up to Follow-up (Week 65))
- Incidence of clinically significant changes in laboratory values(Baseline up to Follow-up (Week 65))
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Hidradenitis Suppurativa Phase 2b Pivotal Study of IzokibepHidradenitis SuppurativaNCT05355805ACELYRIN Inc.176
终止
3 期
Hidradenitis Suppurativa Study of IzokibepHidradenitis SuppurativaNCT05905783ACELYRIN Inc.258
终止
2 期
Psoriatic Arthritis Study of IzokibepPsoriatic ArthritisNCT05623345ACELYRIN Inc.351
已完成
2 期
Targeting IL-17A for Treatment-Resistant DepressionMajor Depressive DisorderNCT04979910Icahn School of Medicine at Mount Sinai7
已完成
1 期
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma GangrenosumPyoderma GangrenosumNCT02733094Technical University of Munich8