Eosinophilic EsophagitisPhase 4NCT05247866
Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
A Phase 4 study testing Eosinophilic Esophagitis (EoE) food introduction-1st, Eosinophilic Esophagitis (E0E) food introduction-2nd and Eosinophilic Esophagitis (EoE) Food introduction-3rd dose in people with Eosinophilic Esophagitis, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Eosinophilic Esophagitis (EoE) food introduction-1st, Eosinophilic Esophagitis (E0E) food introduction-2nd and Eosinophilic Esophagitis (EoE) Food introduction-3rd dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 21 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females age 6 to 25 years
- Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition (Dellon et al, Gastroenterology 2019)
- History of endoscopy with a peak count of >15 eosinophils per high powered field meeting consensus criteria for Eosinophilic Esophagitis1
- History of either milk, egg, soy or wheat induced EoE based on the following criteria in the last two years
- Addition of a single food lead to exacerbation of esophageal eosinophilia (increase of greater than 15 eos/hpf) or
- Removal of a single food lead to normalization of biopsy (esophageal eosinophilia showed less than 6 eos/hpf) AND
Show all 11Show fewer
- History of either milk, egg, soy or wheat induced EoE based on introduction of the food and symptoms in the last 12 months
- Weight > 10 kg
- Ability to remain on stable dose of Proton Pump Inhibitor (PPI) therapy throughout the study
- Girls > 11 years of age must have a negative urine/serum pregnancy test.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Tracheo-esophageal fistulas, inflammatory bowel disease, Barrett's disease, or other significant inflammatory disease of the gastrointestinal tract
- Biopsy evidence of eosinophilic infiltration in any other organ system
- History of significant esophageal procedures e.g. sclerotherapy or esophagectomy
- Systemic immunosuppressant usage in prior 3 months
- Narrow caliber esophagus defined as the inability to pass a 9.5 mm endoscopy into the esophagus
- IgE mediated reaction to food (milk, egg, soy or wheat) being introduced in the last 12 months
Show all 25Show fewer
- Therapy with biologic molecule (e.g. omalizumab, infliximab) in prior 12 months
- Any factors that may pose a significant risk for undergoing anesthesia/sedation
- Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) within 3 months prior to Visit 1.
- Active IgE- mediated milk, egg, wheat or soy allergy based on skin test or history (if those foods are being introduced back into the diet).
- Allergy or known hypersensitivity to the dupilumab.
- Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper Endoscopy and biopsy.
- Past or current disease(s), which in the opinion of the Investigator or the Sponsor, may affect the subject's participation in this study, including but not limited to active autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders).
- Participation in another clinical intervention study in the three months prior to Visit 1.
- Subjects unable to follow the protocol and the protocol requirements.
- Subjects on any experimental drugs or treatments.
- Subjects unable to read/understand English or follow the protocol and the protocol requirements.
- Subjects unable to read/understand English or follow the protocol and the protocol requirements.
- Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit or throughout the trial
- Major elective surgeries are prohibited during the study
- Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Women of children bearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. This includes female patients who experience menarche during the study duration and who are unwilling to follow the precautions for WOCBP.
- Chronic or acute infection requiring treatment with systemic antibiotic, antivirals, or antifungal within 2 weeks of baseline visits
- Patients maybe rescreened after infection resolves
- Participants with active or suspected parasitic infection are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
This study is an open label exploratory study to examine if patients controlled with dupilumab can successful introduce EoE trigger foods back into their diet.
This is a single site study, enrolling subjects 6 to 25 years of age. In the initial 12 week period, patients will be start on dupilumab on the doses used in the phase 3 trials to control disease. If disease is controlled based on histologic and symptom control at week 12 endoscopy, patients will be start on EoE trigger food. The trigger foods will be based on both a combination of history and histology results. The food will have trigger EoE by histology in the last 2 years and symptoms in the last year when reintroduced into the diet. The study will focus on the the four most common foods that trigger EoE: milk, egg, wheat and soy. For the initial food introduction, the subjects will add one serving size of the food daily for 12 weeks. After 12 weeks, the subjects will have a 2nd endoscopy if the 2nd endoscopy is normal, the subjects will increase the trigger food to 2 serving sizes a day or add an additional trigger food. A 3rd endoscopy will be done if the patients increases the food amount or adds a new food at week 36 (12 weeks after adding the new food). If the subject does not increase or add new foods at week 24, the 3rd endoscopy will not be obtained. All subjects will have end of study endoscopy at week 48.
If the subjects have abnormal endoscopy or increase in symptoms, the amount food will be reduced by 50% and repeat endoscopy will be obtained at the same time schedule-12 weeks later.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Eosinophilic Esophagitis (EoE) food introduction-1st, Eosinophilic Esophagitis (E0E) food introduction-2nd, Eosinophilic Esophagitis (EoE) Food introduction-3rd dose, Dupilumab
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eosinophilic Esophagitis (EoE) food introduction-1stDietary supplement
1 serving size of food proven to induce histologic and clinical symptoms in EoE
Eosinophilic Esophagitis (E0E) food introduction-2ndDietary supplement
Either 1 serving size of different food (not food in arm 1) to induce histologic and clinical symptoms in EoE or Increase the food in arm 1 to 2 serving size a day
Eosinophilic Esophagitis (EoE) Food introduction-3rd doseDietary supplement
Either 1 serving size of different food (not food in arm 1 or 2) to induce histologic and clinical symptoms in EoE or Increase the food in arm 2 to 2 serving size a day or unlimited amounts of food arm 1
DupilumabDrug
All patients will receive open label dupilumab at the following doses >12 years of age > 40 kg 300 subcutaneous (SQ) weekly
6-11 years of age 5-15 kg 100 mg SQ every 2 weeks (Q2W) 15-30 kg 200 mg SQ Q2W >30-60 kg 300 mg SQ Q2W
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy)
Dosing:
>12 years of age > 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks
6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W >30-60 kg 300 mg SQ Q2W Receives: Dietary Supplement: Eosinophilic Esophagitis (EoE) food introduction-1st; Dietary Supplement: Eosinophilic Esophagitis (E0E) food introduction-2nd; Dietary Supplement: Eosinophilic Esophagitis (EoE) Food introduction-3rd dose; Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Eosinophils per high power field on esophageal biopsy
Measured: week 24
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Eosinophils per high power field on esophageal biopsy
Measured: week 48
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Eosinophils per high power field on esophageal biopsy
Measured: week 36
Secondary outcomes (3)
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
Min 0-Max-100, lower is better
Measured: week 24
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
Min 0-Max-100, lower is better
Measured: week 36
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
Min 0-Max-100, lower is better
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start16 Jun 2022
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients receive active therapy
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Jonathan Spergel, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247866
- Sponsor's protocol ID
- 21-019416
- Status last verified
- Oct 2025
- First submitted
- 21 Dec 2021
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and published, we will share the study protocol and limited deidentified data.
Publications
Rothenberg ME, Dellon ES, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Sun X, Hamilton JD, Mortensen E, Laws E, Maloney J, Mannent LP, McCann E, Liu X, Glotfelty L, Shabbir A. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):990-1004. doi: 10.1016/S2468-1253(23)00204-2. Epub 2023 Aug 31.
PubMed 37660704McCann E, Chehade M, Spergel JM, Yaworsky A, Symonds T, Stokes J, Tilton ST, Sun X, Kamat S. Validation of the novel Eosinophilic Esophagitis Impact Questionnaire. J Patient Rep Outcomes. 2023 Nov 27;7(1):120. doi: 10.1186/s41687-023-00654-z.
PubMed 38010430Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Aceves S, Sun X, Kosloski MP, Kamal MA, Hamilton JD, Beazley B, McCann E, Patel K, Mannent LP, Laws E, Akinlade B, Amin N, Lim WK, Wipperman MF, Ruddy M, Patel N, Weinreich DR, Yancopoulos GD, Shumel B, Maloney J, Giannelou A, Shabbir A. Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. N Engl J Med. 2022 Dec 22;387(25):2317-2330. doi: 10.1056/NEJMoa2205982.
PubMed 36546624Spergel BL, Ruffner MA, Godwin BC, Liacouras CA, Cianferoni A, Gober L, Hill DA, Brown-Whitehorn TF, Chaiboonma K, Aceves SA, Muir AM, Spergel JM. Improvement in eosinophilic esophagitis when using dupilumab for other indications or compassionate use. Ann Allergy Asthma Immunol. 2022 May;128(5):589-593. doi: 10.1016/j.anai.2022.01.019. Epub 2022 Jan 25.
PubMed 35085819Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, Spechler SJ, Attwood SE, Straumann A, Aceves SS, Alexander JA, Atkins D, Arva NC, Blanchard C, Bonis PA, Book WM, Capocelli KE, Chehade M, Cheng E, Collins MH, Davis CM, Dias JA, Di Lorenzo C, Dohil R, Dupont C, Falk GW, Ferreira CT, Fox A, Gonsalves NP, Gupta SK, Katzka DA, Kinoshita Y, Menard-Katcher C, Kodroff E, Metz DC, Miehlke S, Muir AB, Mukkada VA, Murch S, Nurko S, Ohtsuka Y, Orel R, Papadopoulou A, Peterson KA, Philpott H, Putnam PE, Richter JE, Rosen R, Rothenberg ME, Schoepfer A, Scott MM, Shah N, Sheikh J, Souza RF, Strobel MJ, Talley NJ, Vaezi MF, Vandenplas Y, Vieira MC, Walker MM, Wechsler JB, Wershil BK, Wen T, Yang GY, Hirano I, Bredenoord AJ. Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference. Gastroenterology. 2018 Oct;155(4):1022-1033.e10. doi: 10.1053/j.gastro.2018.07.009. Epub 2018 Sep 6.
PubMed 30009819Wolfset N, Muir AB, Benitez AJ, Williams D, De La Torre I, Ruffner MA, Hill DA, Cazeau C, Angello JT, Radwan A, Durrani S, deMarchi S, Spergel JM. Efficacy of Dupilumab on Facilitated Food Reintroduction in Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2026 May;24(5):1271-1279. doi: 10.1016/j.cgh.2025.08.025. Epub 2025 Sep 30.
PubMed 41038415
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT05247866
- Acronym / sponsor ID
- 21-019416
- Conditions
- Eosinophilic Esophagitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Genzyme, a Sanofi Company
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an open label exploratory study to examine if patients controlled with dupilumab can successful introduce EoE trigger foods back into their diet.
This is a single site study, enrolling subjects 6 to 25 years of age. In the initial 12 week period, patients will be start on dupilumab on the doses used in the phase 3 trials to control disease. If disease is controlled based on histologic and symptom control at week 12 endoscopy, patients will be start on EoE trigger food. The trigger foods will be based on both a combination of history and histology results. The food will have trigger EoE by histology in the last 2 years and symptoms in the last year when reintroduced into the diet. The study will focus on the the four most common foods that trigger EoE: milk, egg, wheat and soy. For the initial food introduction, the subjects will add one serving size of the food daily for 12 weeks. After 12 weeks, the subjects will have a 2nd endoscopy if the 2nd endoscopy is normal, the subjects will increase the trigger food to 2 serving sizes a day or add an additional trigger food. A 3rd endoscopy will be done if the patients increases the food amount or adds a new food at week 36 (12 weeks after adding the new food). If the subject does not increase or add new foods at week 24, the 3rd endoscopy will not be obtained. All subjects will have end of study endoscopy at week 48.
If the subjects have abnormal endoscopy or increase in symptoms, the amount food will be reduced by 50% and repeat endoscopy will be obtained at the same time schedule-12 weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients receive active therapy
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Dietary Supplement: Eosinophilic Esophagitis (EoE) food introduction-1st, Dietary Supplement: Eosinophilic Esophagitis (E0E) food introduction-2nd, Dietary Supplement: Eosinophilic Esophagitis (EoE) Food introduction-3rd dose, Drug: Dupilumab30 patients will be given dupilumab (dose based on current approved doses or used in current EoE clinical trial, q weekly dosing) and monitored for clinical response after 12 weeks of therapy) Dosing: >12 years of age > 40 kg 300 SQ weekly 30- 40 kg 300 mg SQ Q2 weeks 15-29.9 kg 200 mg SQ Q2 weeks 6-11 years of age 5-15 kg 100 mg SQ Q2W 15-30 kg 200 mg SQ Q2W >30-60 kg 300 mg SQ Q2W |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Males or females age 6 to 25 years
- Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition (Dellon et al, Gastroenterology 2019)
- History of either milk, egg, soy or wheat induced EoE based on the following criteria in the last two years
- Weight > 10 kg
- Ability to remain on stable dose of Proton Pump Inhibitor (PPI) therapy throughout the study
Key exclusion criteria (25 listed)
- Tracheo-esophageal fistulas, inflammatory bowel disease, Barrett's disease, or other significant inflammatory disease of the gastrointestinal tract
- Biopsy evidence of eosinophilic infiltration in any other organ system
- History of significant esophageal procedures e.g. sclerotherapy or esophagectomy
- Systemic immunosuppressant usage in prior 3 months
- Narrow caliber esophagus defined as the inability to pass a 9.5 mm endoscopy into the esophagus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eosinophilic Esophagitis (EoE) food introduction-1st1 serving size of food proven to induce histologic and clinical symptoms in EoE | Dietary supplement | Study Group |
| Eosinophilic Esophagitis (E0E) food introduction-2ndEither 1 serving size of different food (not food in arm 1) to induce histologic and clinical symptoms in EoE or Increase the food in arm 1 to 2 serving size a day | Dietary supplement | Study Group |
| Eosinophilic Esophagitis (EoE) Food introduction-3rd doseEither 1 serving size of different food (not food in arm 1 or 2) to induce histologic and clinical symptoms in EoE or Increase the food in arm 2 to 2 serving size a day or unlimited amounts of food arm 1 | Dietary supplement | Study Group |
| DupilumabAll patients will receive open label dupilumab at the following doses >12 years of age > 40 kg 300 subcutaneous (SQ) weekly 6-11 years of age 5-15 kg 100 mg SQ every 2 weeks (Q2W) 15-30 kg 200 mg SQ Q2W >30-60 kg 300 mg SQ Q2W | Drug | Study Group |
Primary outcome
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Time frame: week 24
Eosinophils per high power field on esophageal biopsy
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Time frame: week 48
Eosinophils per high power field on esophageal biopsy
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus)
Time frame: week 36
Eosinophils per high power field on esophageal biopsy
3 secondary outcomes
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
Time frame: week 24
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
Time frame: week 36
Pediatric Eosinophilic Esophagitis Symptom Score (Total Score Based on Pediatric Symptom Score)
Time frame: week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37660704Rothenberg ME, Dellon ES, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Sun X, Hamilton JD, Mortensen E, Laws E, Maloney J, Mannent LP, McCann E, Liu X, Glotfelty L, Shabbir A. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):990-1004. doi: 10.1016/S2468-1253(23)00204-2. Epub 2023 Aug 31.
- Background: PubMed 38010430McCann E, Chehade M, Spergel JM, Yaworsky A, Symonds T, Stokes J, Tilton ST, Sun X, Kamat S. Validation of the novel Eosinophilic Esophagitis Impact Questionnaire. J Patient Rep Outcomes. 2023 Nov 27;7(1):120. doi: 10.1186/s41687-023-00654-z.
- Background: PubMed 36546624Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Aceves S, Sun X, Kosloski MP, Kamal MA, Hamilton JD, Beazley B, McCann E, Patel K, Mannent LP, Laws E, Akinlade B, Amin N, Lim WK, Wipperman MF, Ruddy M, Patel N, Weinreich DR, Yancopoulos GD, Shumel B, Maloney J, Giannelou A, Shabbir A. Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. N Engl J Med. 2022 Dec 22;387(25):2317-2330. doi: 10.1056/NEJMoa2205982.
- Background: PubMed 35085819Spergel BL, Ruffner MA, Godwin BC, Liacouras CA, Cianferoni A, Gober L, Hill DA, Brown-Whitehorn TF, Chaiboonma K, Aceves SA, Muir AM, Spergel JM. Improvement in eosinophilic esophagitis when using dupilumab for other indications or compassionate use. Ann Allergy Asthma Immunol. 2022 May;128(5):589-593. doi: 10.1016/j.anai.2022.01.019. Epub 2022 Jan 25.
- Background: PubMed 30009819Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, Spechler SJ, Attwood SE, Straumann A, Aceves SS, Alexander JA, Atkins D, Arva NC, Blanchard C, Bonis PA, Book WM, Capocelli KE, Chehade M, Cheng E, Collins MH, Davis CM, Dias JA, Di Lorenzo C, Dohil R, Dupont C, Falk GW, Ferreira CT, Fox A, Gonsalves NP, Gupta SK, Katzka DA, Kinoshita Y, Menard-Katcher C, Kodroff E, Metz DC, Miehlke S, Muir AB, Mukkada VA, Murch S, Nurko S, Ohtsuka Y, Orel R, Papadopoulou A, Peterson KA, Philpott H, Putnam PE, Richter JE, Rosen R, Rothenberg ME, Schoepfer A, Scott MM, Shah N, Sheikh J, Souza RF, Strobel MJ, Talley NJ, Vaezi MF, Vandenplas Y, Vieira MC, Walker MM, Wechsler JB, Wershil BK, Wen T, Yang GY, Hirano I, Bredenoord AJ. Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference. Gastroenterology. 2018 Oct;155(4):1022-1033.e10. doi: 10.1053/j.gastro.2018.07.009. Epub 2018 Sep 6.
- Derived from this study: PubMed 41038415Wolfset N, Muir AB, Benitez AJ, Williams D, De La Torre I, Ruffner MA, Hill DA, Cazeau C, Angello JT, Radwan A, Durrani S, deMarchi S, Spergel JM. Efficacy of Dupilumab on Facilitated Food Reintroduction in Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2026 May;24(5):1271-1279. doi: 10.1016/j.cgh.2025.08.025. Epub 2025 Sep 30.
- Individual participant dataSharing planned: Yes. After the study is completed and published, we will share the study protocol and limited deidentified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Spergel, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eosinophilic Esophagitis (EoE) food introduction-1st, Eosinophilic Esophagitis (E0E) food introduction-2nd and Eosinophilic Esophagitis (EoE) Food introduction-3rd dose in people with Eosinophilic Esophagitis, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Eosinophilia (Number of Eosinophils in the Esophagus) (time frame: week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247866, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.