A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- Morning serum cortisol (change from baseline measure)
研究概览
简要总结
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action.
This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female subjects aged ≥ 12 and ≤ 55 years;
- •Written informed consent (parent or guardian must sign when applicable) and assent form, if required;
- •Evidence of eosinophilic esophagitis defined by esophageal mucosal eosinophil count greater than or equal to 24 per HPF (400x magnification) in at least 1 of the esophageal sites biopsied (proximal/middle and/or distal);
- •Lack of histological response to previously administered high dose proton pump inhibitor;
- •Clinical symptoms of eosinophilic esophagitis with at least one of the following symptoms: chest pain or discomfort, dysphagia (difficulty swallowing) or food impaction.
排除标准
- •Known contraindication, hypersensitivity or intolerance to corticosteroids;
- •Any physical, mental, or social condition, history of 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;
- •Oral or esophageal mucosal infection of any type;
- •Any condition affecting the esophageal mucosa or altering esophageal motility other than EoE;
- •Use of systemic (oral or parenteral) or inhaled, intranasal or high-potency dermal topical corticosteroids in the 30 days prior to the esophageal biopsy required for entrance to this study (or prior to EGD if done during the pre-Screening period) or at any time between the biopsy and the Randomization Visit;
- •Adrenal suppression;
- •Any medical condition in which the use of anti-inflammatory or immunosuppressant drugs are required or may be anticipated to be required during the study;
- •Contraindication to EGD or esophageal biopsy or narrowing of the esophagus precluding EGD;
- •History of esophageal or gastric surgery (history of esophageal dilatation is allowed);
- •Gastrointestinal bleeding;
- •Current chronic infection, immunosuppression, immunodeficiency;
- •History or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract;
- •Alcohol or drug abuse;
- •Female subjects who are pregnant or breastfeeding;
- •Participation in a clinical study involving an investigational drug within 30 days of the Screening Visit.
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
EUR-1100 3.0 mg
干预措施: EUR-1100 (Drug)
EUR-1100 1.5 mg
干预措施: EUR-1100 (Drug)
结局指标
主要结局
Morning serum cortisol (change from baseline measure)
时间窗: Screening visit (up to 21 days), week 4, week 8 and follow-up
Standard safety laboratory tests
时间窗: Screening visit (up to 21 days), week 4, week 8 and follow-up
Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
Treatment-emergent adverse events collection
时间窗: Screening visit (up to 21 days), Randomization day, week 2 and week 6(phone visit), week 4 and week 8 (office visit), follow-up (office visit, up to 11 days after week 8 visit)
Physical examination and vital signs collection
时间窗: Screening (up to 21 days), week4, week 8 and follow-up
次要结局
- Esophagoduodenoscopy with multiple biopsies(Screening (up to 21 days) and week 8)
- Patient reported outcomes, and physician global assessment(Screening (up to 21 days), week 4 and 8.)