Clinical Trials

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

Study Purpose

The goal of this clinical trial is to [primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc.] in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]: Does dupilumab or swallowed topical fluticasone improve the diameter of the esophagus more? Does dupilumab or swallowed topical fluticasone reduce inflammation in the esophagus more? Are comparative effective clinical trials feasible in this patient population? Researchers will compare dupilumab 300 mg weekly compared to swallowed fluticasone to see if there is a difference in treatment response. Participants will be asked to:

- Be randomized to either dupilumab sq weekly or swallowed topical fluticasone twice daily.

- Participate in 8 study visits over 52 weeks.

- Complete questionnaires.

- Have an endoscopy with biopsies and EndoFLIP measurements.

- Swallow an Esophageal String Test

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.	Interventional
Eligible Ages	12 Years - 25 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Seen at CHCO for clinical care.

- Age 12 - 25 years old inclusive.

- Weight ≥40 kg at the time of screening visit.

- Confirmed EoE as diagnosed by biopsy with eosinophils ≥15 eosinophils/hpf in at least 2 esophageal regions at screening endoscopy.

- Report of an average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.

- Evidence of fibrostenotic features at time of screening endoscopy (grade 2 or 3 esophageal rings, stricture, delayed passage of barium tablet on fluoroscopy, and/or distensibility ≤15mm)
Exclusion Criteria:
- Esophageal dilation performed at index endoscopy.

- Patients with stricture undergoing dilation at index endoscopy may be rescreened if they meet all other eligibility criteria.

- Patients with acute food impaction will not be enrolled at their therapeutic endoscopy but are eligible for enrollment subsequently if they meet all other eligibility criteria.

- Eligible patients on current STCs can be enrolled but need to be on stable dosing less than or equal to 440 mcg two times daily fluticasone equivalent for 3 months prior to enrollment.

- Patients who have received dupilumab in the past 12 months for any indication are excluded.

- Diet restrictions and PPI use must stay unchanged in the 8 weeks prior to index endoscopy and through the study period.

- Patients with a fasting morning cortisol <5 within 2 months of screening will not be enrolled.

If repeat cortisol levels are normal, patients can be reconsented.

- Known other esophageal disease or esophageal injury (e.g. achalasia, tracheoesophageal fistula, congenital stricture, caustic injury, history of esophageal surgery), inflammatory bowel disease, liver disease, connective tissue disorder, or bleeding disorder.

- Patients with a known gelatin allergy will be excluded from EST collection.

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.	NCT06705387
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.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Arms & Interventions

Arms

Active Comparator: dupilumab (also known as Dupixent)

Active Comparator: fluticasone (also known as Flovent)

Interventions

Biological: - Dupilumab

Subcutaneous injection of 300mg per week for 16 weeks.

Drug: - Fluticasone

Metered dose swallowed topical corticosteroid, given 1760mcg per day for 16 weeks.

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.

Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado/University of Colorado School of Medicine

Aurora, Colorado, 80045

Site Contact

Clinical Research Supervisor | Digestive Health Institute

[email protected]

720-777-8884

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