A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

EsoCap AG0 个研究点目标入组 42 人2023年2月20日

概览

暂无简介。

注册库

who.int

开始日期

2023年2月20日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\. Adult patients aged 18\-70 years;
•2\. Confirmed clinicopathological diagnosis of EoE;
•3\. Active and symptomatic EoE, defined as:
•a. peak eosinophil count \=15 eosinophils/hpf at 2 levels of the esophagus at the screening endoscopy (Visit 2\) as measured in a total of 6 hpfs derived from 6 biopsies, 2 each from the proximal, mid, and distal segment of the esophagus;
•b. either a dysphagia or odynophagia severity sore of \=4 on a 11\-point numeric rating scale (NRS) for \=1 day during the 7 days before Screening (Visit 1\);
•4\. Written informed consent;
•5\. Willingness and ability to comply with the protocol for the duration of the trial;
•6\. Negative pregnancy test at Screening (Visit 1\) and Day 0 (Visit 3\) in women of childbearing potential (i.e. fertile, following menarche and until becoming post\-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy);
•7\. Women of childbearing potential must be willing to use (for a least 3 monthly cycles before the screening endoscopy \[Visit 2] and until 4 weeks after the last intake of IMP) a highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and correctly). Reliable methods for this trial are:
•a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);

•General criteria
•1\. Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the trial period;
•2\. Current or past (within the last 3 months) alcohol or drug abuse;
•3\. Initiation of a diet\-modifying food restriction within 4 weeks before the screening endoscopy (Visit 2\) until the EOT;
•4\. Use of systemic corticosteroids or biologic immunomodulators within 3 months before the screening endoscopy (Visit 2\) until the EOT;
•5\. History of non\-response to treatment of EoE with topical corticosteroid drugs (defined as no improvement of clinical symptoms of EoE after a minimum of 4 weeks corticosteroid therapy used at appropriate doses according to the investigator’s judgment) or requirement of cessation of corticosteroid therapy for EoE treatment due to oral candidiasis or systemic corticosteroid side effects;
•6\. Use of corticosteroids for treatment of EoE within 4 weeks before the screening endoscopy (Visit 2\) until the EOT;
•7\. Use of inhalable (pulmonary or nasal) corticosteroids within 4 weeks before the screening endoscopy (Visit 2\) until the EOT;
•8\. Asthma requiring corticosteroid therapy in the seasonal allergy period according to the investigator’s judgment based on anamnesis until the EOT;
•9\. Change in proton pump inhibitor (PPI) dosing regimen within 4 weeks before the screening endoscopy (Visit 2\) until the EOT;