EUCTR2019-002871-32-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form.
- •-Documented previous diagnosis of EoE by endoscopy (documented diagnosis defined as an esophageal count of =15 eos/hpf on at least 1 esophageal level) and confirmed diagnosis by a centrally-read esophageal biopsy for the purposes of this study (confirmed diagnosis defined as an esophageal count of =15 eos/hpf at 2 or more esophageal levels).
- •Two to 4 biopsies should be obtained from both the proximal and distal esophagus.
- •Biopsies can be taken from the mid-esophagus for additional evaluation.
- •-Must be symptomatic at Visit 1 (run-in period) and Visit 2 (randomization):
- •(a) A patient reported average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the run-in period AND
- •(b) At least 2 days with an episode of dysphagia (Daily DSQ =2) per week between Visit 1 and the Visit 2 (randomization).
- •-Must be adherent to daily diary assessments:
- •(a) Must complete 70% of daily diaries between Visit 1 and Visit 2; AND
- •(b) Must have completed at least 8 of 14 daily diaries in the 14 days prior to randomization.
- •-May be on background medications for EoE and related treatments during the study as long as the background medications have been stable for at least 4 weeks prior to the run-in period.
- •-Body weight of at least 35 kg.
- •-Negative serum pregnancy test for female patients of childbearing potential at Visit1.
- •-Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 16 weeks after last dose if IP.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Other GI disorders such as active Helicobacter pylori infection, history of achalasia,
- •esophageal varices, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, or
- •celiac disease.
- •-Esophageal stricture that prevents the easy passage of a standard endoscope or any critical
- •esophageal stricture that requires dilation during the run-in period.
- •-Use of a feeding tube, or not eating solid food daily during the run-in period.
- •-Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood
- •eosinophil count >1500 eos/µL.
- •-EGPA vasculitis.
- •-Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy.
- •-Current malignancy, or history of malignancy with some specific exceptions.
- •- History of anaphylaxis to any biologic therapy or vaccine.
- •- Current active liver disease:
- •*Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen
- •[HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria.
- •*Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =3 times the
- •upper limit of normal (ULN), confirmed by repeated testing during the run-in period.
- •-Helminth parasitic infection diagnosed within 24 weeks prior to the date informed
- •consent or assent (if applicable) is obtained that has not been treated with or has failed to
- •respond to standard of care therapy.
- •-History of known immunodeficiency disorder including a positive human
- •immunodeficiency virus (HIV) test.
- •-Concomitant use of immunosuppressive medication.
- •-Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to start of the run-in period.
- •-Currently pregnant, breastfeeding, or lactating women.
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