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A U.S. Registry of Eosinophilic Esophagitis Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06693531
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regeneron Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trial Management
Principal Investigator Affiliation Regeneron Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis (EoE)
Arms & Interventions

Arms

: EoE Patients treated with DUPIXENT®

Interventions

Drug: - dupilumab

No investigational agents will be provided. Dupilumab will be prescribed as per usual clinical practice and will not be provided by the sponsor.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rocky Mountain Gastroenterology, Littleton, Colorado

Status

Recruiting

Address

Rocky Mountain Gastroenterology

Littleton, Colorado, 80120

GI Care for Kids LLC, Atlanta, Georgia

Status

Recruiting

Address

GI Care for Kids LLC

Atlanta, Georgia, 30342

Kansas Gastroenterology LLC, Wichita, Kansas

Status

Recruiting

Address

Kansas Gastroenterology LLC

Wichita, Kansas, 67226

Boston Specialists, Boston, Massachusetts

Status

Recruiting

Address

Boston Specialists

Boston, Massachusetts, 02111

Allergy Partners of N.J., P.C., Ocean City, New Jersey

Status

Recruiting

Address

Allergy Partners of N.J., P.C.

Ocean City, New Jersey, 07712

Gastroenterology Group of Rochester LLP, Rochester, New York

Status

Recruiting

Address

Gastroenterology Group of Rochester LLP

Rochester, New York, 14618

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Susquehanna Research Group, Camp Hill, Pennsylvania

Status

Recruiting

Address

Susquehanna Research Group

Camp Hill, Pennsylvania, 17011

Summerville, South Carolina

Status

Recruiting

Address

Palmetto Gastroenterology Clinical Research

Summerville, South Carolina, 29486

Tanner Clinic, Layton, Utah

Status

Recruiting

Address

Tanner Clinic

Layton, Utah, 84041

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