Clinical trial NCT06693531: A U.S. Registry of Eosinophilic Esophagitis Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
Official title: A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eosinophilic Esophagitis (EoE)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2024-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population comprises of patients (≥12 years old) who are initiating treatment with DUPIXENT® for EoE according to the United States Product Information (USPI)

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


Eligibility criteria: Key Inclusion Criteria:

1. Initiating treatment with DUPIXENT® for EoE according to the USPI
2. Able to understand and complete registry-related questionnaires (including adolescents)

Key Exclusion Criteria:

1. Patients who have a contraindication to DUPIXENT® according to the USPI
2. Treatment with DUPIXENT® within the 6 months prior to the screening assessment
3. 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

Primary outcomes:
measure: Demographic characteristic of participants who receive dupilumab for EoE: Age
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Demographic characteristic of participants who receive dupilumab for EoE: Race
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Demographic characteristic of participants who receive dupilumab for EoE: Weight
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Demographic characteristic of participants who receive dupilumab for EoE: Height
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Disease characteristics of participants who receive dupilumab for EoE: Esophagogastroduodenoscopy (EGD)
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Disease characteristics of participants who receive dupilumab for EoE: Dilation/impaction history
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Disease characteristics of participants who receive dupilumab for EoE: Dietary interventions
timeFrame: Baseline and up to 3 years after treatment initiation
measure: Disease characteristics of participants who receive dupilumab for EoE: Medical history
timeFrame: Baseline and up to 3 years after treatment initiation
measure: EoE medication history of participant
timeFrame: Previous 1 year and up to 3 years after treatment initiation
measure: Non-EoE medication history of participant
timeFrame: Previous 3 months and up to 3 years after treatment initiation
measure: Prior dupilumab exposure history of participant
timeFrame: Baseline and up to 3 years after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Sun City
country: United States
facility: Arizona Digestive Health/GI Alliance
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California Keck School of Medicine
state: California
city: Littleton
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Orange City
country: United States
facility: Gastroenterology of Greater Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare, Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: GI Care for Kids LLC
state: Georgia
city: Libertyville
country: United States
facility: Comprehensive Gastrointestinal Health, LLC
state: Illinois
city: Wichita
country: United States
facility: Kansas Gastroenterology LLC
state: Kansas
city: Boston
country: United States
facility: Boston Specialists
state: Massachusetts
city: Flowood
country: United States
facility: GI Associates and Endoscopy Center
state: Mississippi
city: Ocean City
country: United States
facility: Allergy Partners of N.J., P.C.
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: Gastroenterology Group of Rochester LLP
state: New York
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Camp Hill
country: United States
facility: Susquehanna Research Group
state: Pennsylvania
city: Summerville
country: United States
facility: Palmetto Gastroenterology Clinical Research
state: South Carolina
city: Southlake
country: United States
facility: GI Alliance
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Tacoma
country: United States
facility: Washington Gastroenterology, GIA
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: