NCT05247866

Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis

Completed Phase 4 Results posted Last updated 10 November 2025

What this trial tests

Phase 4 trial testing Eosinophilic Esophagitis (EoE) food introduction-1st in Eosinophilic Esophagitis in 21 participants. Completed in 21 January 2025.

Timeline

16 June 2022

Primary endpoint
21 January 2025

21 January 2025

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	16 June 2022
Primary completion	21 January 2025
Estimated completion	21 January 2025
Sites	1 location across United States

Drugs / interventions tested

• Eosinophilic Esophagitis (EoE) food introduction-1st
• Eosinophilic Esophagitis (E0E) food introduction-2nd
• Eosinophilic Esophagitis (EoE) Food introduction-3rd dose
• Dupilumab (DUPILUMAB) — full drug profile →

Conditions studied

• Eosinophilic Esophagitis — all drugs for Eosinophilic Esophagitis →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 6 to 25, any sex, with Eosinophilic Esophagitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Esophageal Eosinophilia (Number of Eosinophils in the Esophagus) Primary · week 24

Eosinophils per high power field on esophageal biopsy

Group	Value	95% CI
Study Group	5.3	± 8.9

Esophageal Eosinophilia (Number of Eosinophils in the Esophagus) Primary · week 48

Eosinophils per high power field on esophageal biopsy

Group	Value	95% CI
Study Group Month 12	2.6	± 4.5

Esophageal Eosinophilia (Number of Eosinophils in the Esophagus) Primary · week 36

Eosinophils per high power field on esophageal biopsy

Group	Value	95% CI
Study Group Month 9	1.3	± 2.8

Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score) Secondary · week 24

Min 0-Max-100, lower is better

Group	Value	95% CI
Study Group	7.7	± 7.7

Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score) Secondary · week 36

Min 0-Max-100, lower is better

Group	Value	95% CI
Study Group	5.1	± 6.4

Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score) Secondary · week 48

Min 0-Max-100, lower is better

Group	Value	95% CI
Study Group	8	± 11.3

Rate of Maintenance of Remission (Less Than <6 Eos/Hpf) in Esophageal Biopsy Secondary · week 24

Less than 6 eosinophils per high power field in peak count in esophageal biopsy

Group	Value	95% CI
Study Group	12

Rate of Maintenance of Remission (Less Than <6 Eos/Hpf) in Esophageal Biopsy Secondary · week 36

Less than 6 eosinophils per high power field in peak count in esophageal biopsy

Group	Value	95% CI
Study Group	13

Rate of Maintenance of Remission (Less Than <6 Eos/Hpf) in Esophageal Biopsy Secondary · week 48

Less than 6 eosinophils per high power field in peak count in esophageal biopsy

Group	Value	95% CI
Study Group	11

Rate of Maintenance of Remission (Less Than <15 Eos/Hpf) in Esophageal Biopsy Secondary · Week 24

Less than 15 eosinophils per high power field in peak count in esophageal biopsy

Group	Value	95% CI
Study Group	14

Rate of Maintenance of Remission (Less Than <15 Eos/Hpf) in Esophageal Biopsy Secondary · Week 36

Less than 15 eosinophils per high power field in peak count in esophageal biopsy

Group	Value	95% CI
Study Group	13

Rate of Maintenance of Remission (Less Than <15 Eos/Hpf) in Esophageal Biopsy Secondary · Week 48

Less than15 eosinophils per high power field in peak count in esophageal biopsy

Group	Value	95% CI
Study Group	13

Adverse events — posted to ClinicalTrials.gov

Time frame: Enrollment until end of follow-up (up to 52 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Group

Serious: 1/21 (5%)

Deaths: 0/21

Serious adverse events (1 terms)

Reaction	System	Study Group
Depression	Psychiatric disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Study Group
Upper respiratory infection	Infections and infestations	—
Injection Reaction	Skin and subcutaneous tissue disorders	—
headache	Nervous system disorders	—
abdominal Pain	Gastrointestinal disorders	—
nausea	Gastrointestinal disorders	—
diarrhea	Gastrointestinal disorders	—
Congestion	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Depression.

Data from ClinicalTrials.gov NCT05247866 adverse events section.

Sponsor's own description

Eosinophilic Esophagitis (EoE) is a food driven non-immunoglobulin E (IgE) mediated disease involving eosinophils and type 2 inflammation. Current therapies include diet and the off label use of medications including proton pump inhibitors, topical steroids or biologics. Food elimination creates a decrease quality of life in many children. The goal of the study is to examine a T2 inhibitor (dupilumab) can allow successful reintroduction of allergic EoE foods into the diet. This is a single site study, enrolling subjects 6 to 25 years of age.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Allergy: Mechanistic insights into new methods of prevention and therapy.
   Akdis CA, Akdis M, Boyd SD, Sampath V, et al · · 2023 · cited 52× · PMID 36652536 · DOI 10.1126/scitranslmed.add2563
2. The role of biologics in pediatric food allergy and eosinophilic gastrointestinal disorders.
   Sindher SB, Barshow S, Tirumalasetty J, Arasi S, et al · · 2023 · cited 24× · PMID 36872039 · DOI 10.1016/j.jaci.2023.01.007
3. Current and Novel Therapies for Eosinophilic Gastrointestinal Diseases.
   Marasco G, Visaggi P, Vassallo M, Fiocca M, et al · · 2023 · cited 23× · PMID 37894846 · DOI 10.3390/ijms242015165
4. The New Therapeutic Frontiers in the Treatment of Eosinophilic Esophagitis: Biological Drugs.
   Ridolo E, Barone A, Ottoni M, Peveri S, et al · · 2024 · cited 9× · PMID 38338983 · DOI 10.3390/ijms25031702
5. A Practical Update on Pediatric Eosinophilic Esophagitis.
   Votto M, De Filippo M, Caimmi S, Indolfi C, et al · · 2023 · cited 9× · PMID 37892285 · DOI 10.3390/children10101620
6. From Pathogenesis to Treatment: Targeting Type-2 Inflammation in Eosinophilic Esophagitis.
   Barchi A, Mandarino FV, Yacoub MR, Albarello L, et al · · 2024 · cited 8× · PMID 39334846 · DOI 10.3390/biom14091080
7. Efficacy of Dupilumab on Facilitated Food Reintroduction in Eosinophilic Esophagitis.
   Wolfset N, Muir AB, Benitez AJ, Williams D, et al · · 2026 · cited 1× · PMID 41038415 · DOI 10.1016/j.cgh.2025.08.025