Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of conjunctivitis events by severity
研究概览
简要总结
The primary objective of the study is to characterize the clinical phenotype(s) of DUPIXENT®-associated conjunctivitis events.
The secondary objectives of the study are to characterize the course of conjunctivitis events during the observation period and collect and assess data on treatment for conjunctivitis events and its effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with DUPIXENT® for AD (per the current US Prescribing Information) should be ongoing, and have been initiated at least 8 weeks prior to study enrollment. NOTE: A single missed dose in the 8 weeks prior to enrollment is allowed.
- •Patients with protocol-specified conjunctivitis events must present with active bilateral conjunctivitis (with or without cornea or eyelid involvement) diagnosed by the ophthalmologist (investigator) which meets all of the following criteria:
- •Developed (or significantly worsened) while receiving treatment with DUPIXENT® for AD
- •Is clinically significant (eg, moderate-to-severe, extensive, persistent, etc) as determined by the investigator
- •There is a suspected causal relationship between DUPIXENT® and conjunctivitis because:
- •Conjunctivitis is a new-onset condition or an unusual worsening of a preexisting condition (eg, significantly more severe, more extensive, or more protracted than ever before) AND
- •No alternative explanation is more plausible, in the opinion of the investigator
- •Reference patients must have AD treated with current ongoing treatment with DUPIXENT® for equal or longer duration as compared to group 1, with no clinical signs of ocular inflammation noted during the entire DUPIXENT® treatment
排除标准
- •Any known medical, social, or personal limitations that are likely to restrict the patient's ability to undergo study visits and complete study procedures (as assessed by the investigator), including hypersensitivity or other contraindications to the anesthetic eye drops used during the ophthalmological examination.
- •NOTE: Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Patients with qualifying conjunctivitis events
干预措施: dupilumab (Drug)
Patients with no clinical signs of eye inflammation
干预措施: dupilumab (Drug)
结局指标
主要结局
Proportion of conjunctivitis events by severity
时间窗: Initial Visit (Day 1) up to week 52
Severity is based on the nature of the event, intensity of signs and/or symptoms, current functional impairment, and potential long-term health hazards related to the event. 3-point scale: Mild, Moderate or Severe.
Proportion of patients with conjunctivitis event resolution
时间窗: Up to week 52
Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events
时间窗: Up to week 52
Baseline Ophthalmologist Diagnosis
时间窗: Initial Visit (Day 1)
Diagnosis includes: symptoms and morphological features of conjunctivitis
Proportion of patients with symptoms
时间窗: Initial Visit (Day 1) up to week 52
Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc
Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved
时间窗: Up to week 52
Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue
时间窗: Up to week 52 or resolution
Measured by conjunctival impression sample (EyeprimTM) for cytology and RNA sequencing
Proportion of patients in each category of ophthalmologist diagnoses
时间窗: Initial Visit (Day 1)
Symptoms / Morphological features
Proportion of patients with morphological features
时间窗: Initial Visit (Day 1) up to week 52
Morphological features include but are not limited to: bulbar redness, limbal redness, lid redness, lid roughness, etc. and associated conditions may include blepharitis, keratitis, etc.
Ophthalmologists assessment of treatment effectiveness, overall and by clinical phenotype based on a 5-point scale.
时间窗: Up to week 52
Treatment Effectiveness assessed on a 5-point scale: Poor, Fair, Good, Very Good, Excellent
次要结局
未报告次要终点