Six Month Safety Follow-up Study for PR-021 [Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Eosinophilic Esophagitis Subjects]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Morning serum cortisol (change from baseline measure)
研究概览
简要总结
This purpose of this study is the long-term follow-up of glucocorticosteroid-related adverse events and hypothalamic-pituitary-adrenal axis (HPA) suppression in subjects after discontinuation of study drug received in the PR-021 study (Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis). The study will also provide the opportunity to better understand the natural course of eosinophilic esophagitis and define the treatment modalities of eosinophilic esophagitis with EUR-1100, such as the need for chronic maintenance or intermittent treatment.
All subjects who complete PR-021 will be offered the opportunity to participate in this study. The duration of this follow-up study is six months, during which subjects will visit the clinic for safety evaluation and clinical symptom assessment at the screening, Week 8, Week 16, and Week 24 visits. Additional phone visits will occur at Week 4, Week 12, and Week 20.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject completed full participation in Study PR-021 (Subjects discontinued prematurely from PR-021 due to HPA axis suppression will be eligible for study PR-022)
- •Written informed consent (parent or legal guardian must sign when applicable) and assent form, if required
- •Willing and able to adhere to all study procedures
排除标准
- •Subjects already requiring medications or procedures for the treatment of EoE at the time of enrollment into the follow-up study, such as systemic (oral or parenteral) or inhaled corticosteroids, esophageal dilation, Proton Pump Inhibitors (PPIs) and/or dietary restrictions; in the case of subjects already on PPIs and /or dietary restrictions during Study PR-021, only subjects requiring an increase in dosage of PPIs and/or new dietary restrictions because of worsening of symptoms will be excluded
- •Any physical, mental, or social condition, history or concurrent illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study
- •Contraindication to esophagogastroduodenoscopy (EGD) or esophageal biopsy or narrowing of the esophagus precluding EGD
- •Female subjects who are pregnant or breastfeeding
- •Participation in a clinical study involving an investigational drug or investigational device
研究组 & 干预措施
PR-021 Eosinophilic Esophagitis (EoE) Subjects
Subjects who received study drug and completed PR-021 study
干预措施: EUR-1100 (Drug)
PR-021 Eosinophilic Esophagitis (EoE) Subjects
Subjects who received study drug and completed PR-021 study
干预措施: Placebo (Drug)
结局指标
主要结局
Morning serum cortisol (change from baseline measure)
时间窗: Baseline, Week 8, Week 16, and Week 24
Standard safety laboratory tests (change from baseline measure)
时间窗: Baseline, Week 8, Week 16, and Week 24
Hematology, serum chemistry, liver function tests, urinalysis, urine chemistry
Treatment-emergent adverse events collection (change from baseline measure)
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Physical examination and vital signs collection (change from baseline measure)
时间窗: Baseline, Week 8, Week 16, and Week 24
次要结局
- Esophagoduodenoscopy with multiple biopsies(Week 24)
- Patient reported outcomes and physician global assessment(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)