Dupilumab for Eosinophilic Esophagitis With Severe Strictures (DESTRICT Study)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Histologic Response to Dupilumab
研究概览
简要总结
The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.
Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered in the clinic at the enrollment visit (day 0) and participants (or their caregivers) will receive training on how to self-administer the remaining doses.
Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.
At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned female at birth (AFAB) may be asked to come to the clinic for a urine pregnancy test.
详细描述
This research study aims to learn how well an FDA-approved drug called dupilumab works in treating patients with Eosinophilic Esophagitis (EoE) and severe strictures (esophageal narrowing).
This is an open-label study, which means everyone enrolled will receive dupilumab. Dupilumab is a weekly injection, administered using a needle under the skin (subcutaneous injection). Dupilumab is already approved by the FDA for treating EoE.
Participants will be part of the study for approximately 52-64 weeks. In-person study visits will occur at specific intervals. Study Visits will happen at the beginning of the study (screening), day 0 (enrollment), and weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52 post-enrollment.
Upper Endoscopies are performed at screening and weeks 12, 24, and 52 (or if participation ends early).
Pregnancy Status Check: 12 weeks after the last dose of dupilumab, participants Assigned Female at Birth (AFAB) may return to the clinic for a urine pregnancy test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mepolizumab (Nucala),
- •reslizumab (Cinqair, Cinqaero),
- •benralizumab (Fasenra),
- •cendakimab,
- •tezepelumab (Tezspire),
- •barzolvolimab, etc.
- •Prior esophageal resection (surgery to remove the esophagus).
- •Participants taking blood thinners (such as coumadin, warfarin, heparin, etc.) who are unable to stop taking them for a brief period prior to EGD (as required by normal clinical practice).
- •Recent vaccination with a live (attenuated) vaccine (within 4 weeks of screening). Live vaccines include:
- •Chickenpox (varicella),
- •FluMist and Intranasal influenza,
- •Measles (rubeola),
- •Oral polio,
- •Oral typhoid,
- •Smallpox (vaccinia),
- •Yellow fever,
- •Bacille Calmette-Guerin
- •Rotavirus
- •Combination vaccines of any of the above.
- •Study doctor's determination that it would not be medically safe to complete an EGD.
- •Inability to read or understand English.
- •Currently pregnant or breastfeeding.
- •Currently in screening or eligible for another study of dupilumab (Dupixent).
排除标准
- 未提供
研究组 & 干预措施
Open Label dupilumab
Open label dupilumab 300mg injection given subcutaneously weekly, for 52 weeks.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Histologic Response to Dupilumab
时间窗: 24 weeks
Proportion (percentage) of patients with histologic response, defined as \<15 eosinophils per high-power field (eos/hpf), after 24 weeks of dupilumab 300mg weekly.
次要结局
- Change in Histologic Severity(24 weeks)
- Change in Minimum Esophageal Caliber(24 weeks)
- Decrease in Number of Dilations(52 weeks)
- Change in Endoscopic Severity(24 weeks)