Eosinophilic Gastrointestinal Disorders (EGIDs)NCT07257835
Dupilumab Therapy for EGIDs
An observational study of Eosinophilic Gastrointestinal Disorders (EGIDs), run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Eosinophilic Gastrointestinal Disorders (EGIDs)
- What is being tested?
- Dupilumab - Standard Dose and subcutaneous injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with refractory eosinophilic gastrointestinal disorders who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.
Who may be able to join
- Clinical diagnosis of Refractory Peptic Ulcers
- with Refractory Eosinophilic Gastrointestinal Disorders
Who cannot join
- with Active Helicobacter pylori infection at present.
- with Inflammatory bowel disease
- with Parasite infection
- with Cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
201102
Shanghai
Zhi-heng Huang, 021-64931727, yhuang815@163.com
About this study
Official title: Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children
This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.
Read the detailed description
Eosinophilic Gastrointestinal Disorders (EGIDs) are chronic inflammatory diseases caused by extensive infiltration of eosinophils in the gastrointestinal tract. Treatment requires long-term dietary avoidance, long-term oral administration of high-dose omeprazole, as well as hormones and immunosuppressants, but the results are unsatisfactory and the side effects are significant. Dupilumab is a fully human monoclonal antibody (IgG4 type) that can specifically bind to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes to inhibit the signal transduction of IL-4 and IL-13. Current studies have shown that subcutaneous treatment with dupilumab for eosinophilic esophagitis has significant efficacy. In recent years, this drug has been reported to be used for various forms of gastrointestinal diseases such as eosinophilic gastritis, duodenitis, etc., with remarkable efficacy. In recent years, there has been an increasing number of children with refractory eosinophilic gastrointestinal diseases, which can easily cause repeated large ulcers, perforation, and stenosis in the gastrointestinal tract, requiring surgical intervention. This disease seriously affects the growth and development of children and urgently requires better treatment options. This study aims to evaluate the efficacy and tolerance of dupilumab in children with refractory eosinophilic gastrointestinal diseases.
- Being tested
- Dupilumab - Standard Dose, subcutaneous injection
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab - Standard DoseDrug
Dose: For patients with weight ≥ 15kg but < 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but < 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.
subcutaneous injectionDevice
Dose: For patients with weight ≥ 15kg but < 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but < 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.
| Study group | Role | What they receive |
|---|---|---|
| The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump | Not described Receives: Drug: Dupilumab - Standard Dose; Device: subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic response rate
The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.
Measured: week12, week26, week52
Secondary outcomes (1)
Relative Change of Peak Eosinophil Counts in the Stomach
We will determine the relative change from baseline in the peak eosinophil count in the five high-power fields (HPFs) with the highest eosinophil density in the antrum and/or body of the stomach after intervention.
Measured: week12，week26，week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Gastrointestinal Disorders (EGIDs)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257835
- Sponsor's protocol ID
- Dupilumab in EGIDs
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children
- ClinicalTrials.gov ID
- NCT07257835
- Acronym / sponsor ID
- Dupilumab in EGIDs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.
Detailed description
Eosinophilic Gastrointestinal Disorders (EGIDs) are chronic inflammatory diseases caused by extensive infiltration of eosinophils in the gastrointestinal tract. Treatment requires long-term dietary avoidance, long-term oral administration of high-dose omeprazole, as well as hormones and immunosuppressants, but the results are unsatisfactory and the side effects are significant. Dupilumab is a fully human monoclonal antibody (IgG4 type) that can specifically bind to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes to inhibit the signal transduction of IL-4 and IL-13. Current studies have shown that subcutaneous treatment with dupilumab for eosinophilic esophagitis has significant efficacy. In recent years, this drug has been reported to be used for various forms of gastrointestinal diseases such as eosinophilic gastritis, duodenitis, etc., with remarkable efficacy. In recent years, there has been an increasing number of children with refractory eosinophilic gastrointestinal diseases, which can easily cause repeated large ulcers, perforation, and stenosis in the gastrointestinal tract, requiring surgical intervention. This disease seriously affects the growth and development of children and urgently requires better treatment options. This study aims to evaluate the efficacy and tolerance of dupilumab in children with refractory eosinophilic gastrointestinal diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump | – | Drug: Dupilumab - Standard Dose, Device: subcutaneous injection |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with refractory eosinophilic gastrointestinal disorders who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Refractory Peptic Ulcers
- with Refractory Eosinophilic Gastrointestinal Disorders
Key exclusion criteria (4 listed)
- with Active Helicobacter pylori infection at present.
- with Inflammatory bowel disease
- with Parasite infection
- with Cancer
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 |
|---|---|---|
| Dupilumab - Standard DoseDose: For patients with weight ≥ 15kg but < 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but < 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week. | Drug | The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump |
| subcutaneous injectionDose: For patients with weight ≥ 15kg but < 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but < 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week. | Device | The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump |
Primary outcome
Endoscopic response rate
Time frame: week12, week26, week52
The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.
1 secondary outcome
Relative Change of Peak Eosinophil Counts in the Stomach
Time frame: week12，week26，week52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Eosinophilic Gastrointestinal Disorders (EGIDs)
RecruitingObservational study
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Gastrointestinal Disorders (EGIDs), run by Children's Hospital of Fudan University at 1 site in China.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Dec 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Huang (021-64931727, yhuang815@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic response rate (time frame: week12, week26, week52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.