NL-OMON52665招募中2 期
A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis - ACESO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- EsoCap AG
- 入组人数
- 10
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 64（—）
入选标准
- •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/high-powered field (hpf) at 2 levels
- •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
- •b. either a dysphagia or odynophagia severity sore of >=4 on a 11-point numeric
- •scale 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
- •6. Negative pregnancy test at Screening (Visit 1) and Day 0 (Visit 3) in women
- •childbearing potential (i.e. fertile, following menarche and until becoming
- •post-menopausal unless permanently sterile. Permanent sterilization methods
- •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
- •with inhibition of ovulation (oral, intravaginal, transdermal);
- •b. progestogen-only hormonal contraception associated with inhibition of
- •(oral, injectable, implantable);
- •c. intrauterine device or intrauterine hormone-releasing system;
- •d. bilateral tubal occlusion;
- •e. a vasectomized sexual partner;
- •f. sexual abstinence (only accepted as true abstinence when this is in line
- •preferred and usual lifestyle of the patient; periodic abstinence [e.g.
- •ovulation, symptothermal, post-ovulation methods, and withdrawal] is not an
- •acceptable method of contraception).
排除标准
- •1. Women who are pregnant, lactating, possibly pregnant or planning a pregnancy
- •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
- •endoscopy (Visit 2) until EOT;
- •4. Use of systemic corticosteroids or biologic immunomodulators within 3 months
- •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
- •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
- •screening endoscopy (Visit 2) until the EOT;
- •10. Use of systemic leukotriene receptor antagonists, immunosuppressant
- •therapy, or chronic
- •oral or systemic anticoagulants (such as coumarin derivates, novel oral and
- •subcutaneous
- •anticoagulants) within 2 weeks before Screening (Visit 1) until the EOT;
- •11. Unable to swallow a test tablet of about the size of the IMP capsule used
- •in the trial;
- •12. History of diabetes mellitus;
- •13. Other severe comorbid condition, concurrent medication, or other issue that
- •renders the
- •patient unsuitable to participate in the trial in the judgment of the
- •investigator, including
- •but not limited to: comorbid condition with an estimated life expectancy of <=12
- •dialysis, severe pulmonary (requiring home oxygen, uncontrolled chronic
- •obstructive
- •pulmonary disease Gold III/IV) or cardiovascular conditions (heart failure New
- •Heart Association III and IV, uncontrolled hypertension systolic blood pressure
- •repeated measurement >180mmHg);
- •14. History of cancer (except non-melanoma skin cancer, or carcinoma in situ of
- •treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy,
- •hormone therapy for cancer treatment, targeted therapy or gene therapy) within
- •12 months before Screening (Visit 1) until the EOT;
- •15. Known intolerability or hypersensitivity to mometasone furoate or any of
- •excipients (e.g. bovine gelatin, polyvinyl alcohol, polyvinyl acetate,
- •glycerol, sorbitol);
- •16. Systemic autoimmune disorders or any condition requiring immunosuppression
- 另有 7 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusActive eosinophilic esophagitisMedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-000082-16-PLEsoCap AG42
进行中（未招募）
4 期
Can treatment with Cerebrolysin improve recovery after acute ischemic stroke?Radiologically confirmed acute ischemic stroke with onset within 72 hours prior to screeningCirculatory SystemAcute ischemic strokeISRCTN88122184The foundation for the study of neuroscience and neuroregeneration290
进行中（未招募）
1 期
A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusActive eosinophilic esophagitisMedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-000082-16-NLEsoCap AG42
进行中（未招募）
1 期
A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagusEUCTR2020-000082-16-DEEsoCap AG42
已完成
1 期
A placebo-controlled, randomized, double-blind trial to investigate the impact of dapagliflozin on the development of diabetic ketoacidosis and intermediate metabolism in type 1 diabetes using a dual stable tracer method: A safety study investigating the fuel shift theory in the human modelE10Type 1 diabetes mellitusDRKS00021284Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie17