NL-OMON56323招募中不适用
A Phase 1b/2a, Open Label Trial Evaluating the Safety, Pharmacokinetics, and Efficacy of EP-104IAR in Adults with Eosinophilic Esophagitis (RESOLVE) - A study of EP-104IAR in Adults with Eosinophilic Esophagitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adults 18 to 75 years of age, inclusive
- •2. Symptomatic EoE defined as:
- •a. SDI >= 5 at screening and baseline
- •b. Confirmed historical diagnosis of EoE with PEC > 15/hpf
- •3. For women of childbearing potential, a negative pregnancy test (at baseline)
- •and willing to use a
- •highly effective method of birth control between baseline and end of study
- •4. Willing and able to adhere to study-related procedures and visit schedule
- •5. Willing and able to provide informed consent
排除标准
- •1. Any concomitant esophageal disease and relevant GI disease including but not
- •limited to eosinophilic gastritis or enteritis (defined by clinicopathologic
- •features), erosive esophagitis Los Angeles grade C or higher, Barrett*s
- •esophagus, previous esophageal surgery, Celiac disease, inflammatory bowel
- •disease, or any condition or history of illness or laboratory abnormality that
- •in the investigator*s judgment might interfere with study procedures or ability
- •to complete the study,
- •Note: Participants with occasional gastroesophageal reflux disease (GERD)
- •symptoms without severe (Los Angeles grade C or higher)
- •endoscopic erosive reflux esophagitis are permitted
- •2. Presence of oral or esophageal mucosal infection of any type (bacterial,
- •viral, or fungal)
- •3. Any oropharyngeal or dental condition that prevents normal eating
- •4. Known severe esophageal motility disorders other than EoE
- •5. Contraindication to or factors that substantially increase the risk
- •associated with EGD or esophageal biopsy, or narrowing of the esophagus that
- •precludes EGD with a standard 9-10 mm endoscope, stricture requiring dilation
- •within the 8 weeks prior to Screening, or the need for dilation prior to EGD at
- •A history or presence of any condition for which the use of corticosteroids is
- •contraindicated (e.g., insulin-dependent diabetes mellitus, Cushing*s syndrome,
- •Addison*s disease, cortisol-related endocrinopathy, etc.)
- •6.Known active or quiescent systemic fungal, bacterial (including
- •tuberculosis), viral (including human immunodeficiency virus [HIV], hepatitis B
- •virus [HBV], or hepatitis C virus [HCV]), or parasitic infections, or ocular
- •herpes simplex. Or any infection requiring intravenous [IV] antibiotics within
- •4 weeks of baseline, or oral antibiotics within 2 weeks of baseline.
- •7. Known hypersensitivity, or intolerance to corticosteroids, or to any of the
- •ingredients in the investigational medicinal product, including carboxymethyl
- •cellulose, hyaluronic acid, and polysorbate 80, or to the ingredients in
- •Synacthen (used in the ACTH stimulation test)
- •8. Use of systemic corticosteroids within 60 days prior to baseline, or
- •swallowed topical corticosteroids within 60 days prior to baseline, or extended
- •use of high-potency dermal topical corticosteroids within 60 days prior to
- •09. Use of a new inhaled or intranasal corticosteroid within 60 days prior to
- •baseline, or a change in dose of an inhaled or intranasal corticosteroid within
- •60 days of baseline (a temporary dose change lasting <= 14 days is permitted)
- •10. Initiation of an elimination diet or elemental diet within 30 days prior to
- •baseline (dietary therapy must remain stable throughout the study)
- •11. Use of biologic immunomodulators in the 90 days prior to baseline
- •12. Use of immunosuppressive drugs, or potent cytochrome CYP3A4 inhibitors in
- •the 90 days prior to baseline
- •13. Initiated, discontinued, or changed dosage regimen of PPIs for any
- •condition such as GERD or allergic rhinitis within 4 weeks prior to baseline.
- •Doses must remain stable throughout the study
- •14. Morning serum cortisol level <= 5 µg/dL (138 nmol/L) at Screening visit
- •15. Use of another investigational product within the 30 days prior to
- •baseline, or an investigational biologic within 90 days prior to baseline, or
- •current/planned participation
研究者
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