Evaluation of Tildrakizumab in the Treatment of Ocular Sequelae in Lyell syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint of this study is the change in tear film break-up time (TBUT), measured in seconds, between baseline (Day 0) and post-treatment follow-up visits
研究概览
简要总结
To evaluate the efficacy of Tildrakizumab on the ophthalmological sequelae of Lyell syndrome.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Post-treatment Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years old)
- •Non-pregnant and not breastfeeding (if female)
- •Presenting with ocular sequelae of Lyell Syndrome
- •Able to provide informed consent
- •Covered by a social security scheme.
- •Patients with a history of SJS/TEN with persistent ocular symptoms or signs compatible with chronic ocular surface inflammation.
- •Visual acuity allowing assessment procedures.
- •Clinical stability allowing safe ocular examination
排除标准
- •Pregnant or breastfeeding woman
- •<18 years old
- •Receipt of a live attenuated vaccine within 4 weeks prior to inclusion and/or need for a live attenuated vaccine during the study or within 17 weeks after the last dose of Tildrakizumab
- •Known hypersensitivity to tildrakizumab
- •Patients with a chronic, recurrent, or recent serious infection, or with any suspected clinically relevant active infection
- •Active infectious keratitis (bacterial, viral, fungal)
- •Corneal ulcer threatening perforation
- •Severe non-SJS/TEN–related ocular diseases (e.g., advanced glaucoma, retinal disease).
结局指标
主要结局
The primary efficacy endpoint of this study is the change in tear film break-up time (TBUT), measured in seconds, between baseline (Day 0) and post-treatment follow-up visits
The primary efficacy endpoint of this study is the change in tear film break-up time (TBUT), measured in seconds, between baseline (Day 0) and post-treatment follow-up visits
Secondary efficacy endpoints will consist of patient-reported outcome measures designed to capture the subjective impact of treatment on ocular symptoms and vision-related quality of life.
Secondary efficacy endpoints will consist of patient-reported outcome measures designed to capture the subjective impact of treatment on ocular symptoms and vision-related quality of life.
次要结局
- Clinical Safety Monitoring
- Patient-Reported Tolerability via DL-QI
研究者
Sponsor
Scientific
TOXILYON