A U.S. Registry of Eosinophilic Esophagitis Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
- Registration Number
- NCT06693531
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE.
Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward.
Patient questionnaires will measure the following:
* How EoE makes one feel
* EoE symptoms
* How EoE affects quality-of-life
* How EoE impacts aspects of daily life
* How difficult it is to swallow
* How EoE symptoms have changed throughout the study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Initiating treatment with DUPIXENT® for EoE according to the USPI
- Able to understand and complete registry-related questionnaires (including adolescents)
Key
- Patients who have a contraindication to DUPIXENT® according to the USPI
- Treatment with DUPIXENT® within the 6 months prior to the screening assessment
- Participation in an ongoing interventional study on or within 6 months of the baseline assessment. Once enrolled in registry, participation is allowed in other ongoing studies (at the discretion of the registry investigator)
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EoE Patients treated with DUPIXENT® dupilumab -
- Primary Outcome Measures
Name Time Method Demographic characteristic of participants who receive dupilumab for EoE: Age Baseline and up to 3 years after treatment initiation Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD) Baseline and up to 3 years after treatment initiation Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions Baseline and up to 3 years after treatment initiation Disease characteristics of participants who receive dupilumab for EoE: Medical history Baseline and up to 3 years after treatment initiation Demographic characteristic of participants who receive dupilumab for EoE: Race Baseline and up to 3 years after treatment initiation Demographic characteristic of participants who receive dupilumab for EoE: Weight Baseline and up to 3 years after treatment initiation EoE medication history of participant Previous 1 year and up to 3 years after treatment initiation Prior dupilumab exposure history of participant Baseline and up to 3 years after treatment initiation Demographic characteristic of participants who receive dupilumab for EoE: Height Baseline and up to 3 years after treatment initiation Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history Baseline and up to 3 years after treatment initiation Non-EoE medication history of participant Previous 3 months and up to 3 years after treatment initiation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Emory Healthcare, Emory Clinic
🇺🇸Atlanta, Georgia, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
Arizona Digestive Health/GI Alliance
🇺🇸Sun City, Arizona, United States
Rocky Mountain Gastroenterology
🇺🇸Littleton, Colorado, United States
Gastroenterology of Greater Orlando
🇺🇸Orange City, Florida, United States
GI Care for Kids LLC
🇺🇸Atlanta, Georgia, United States
Comprehensive Gastrointestinal Health, LLC
🇺🇸Libertyville, Illinois, United States
Kansas Gastroenterology LLC
🇺🇸Wichita, Kansas, United States
Boston Specialists
🇺🇸Boston, Massachusetts, United States
GI Associates and Endoscopy Center
🇺🇸Flowood, Mississippi, United States
Allergy Partners of N.J., P.C.
🇺🇸Ocean City, New Jersey, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Gastroenterology Group of Rochester LLP
🇺🇸Rochester, New York, United States
Susquehanna Research Group
🇺🇸Camp Hill, Pennsylvania, United States
Palmetto Gastroenterology Clinical Research
🇺🇸Summerville, South Carolina, United States
GI Alliance
🇺🇸Southlake, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Washington Gastroenterology, GIA
🇺🇸Tacoma, Washington, United States