Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
Study NCT ID:
NCT07257835
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-08-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dupilumab Therapy for EGIDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}, {'id': 'D007279', 'term': 'Injections, Subcutaneous'}], 'ancestors': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample, stool samples and biopsy samples during endoscopy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse event', 'timeFrame': 'within one year', 'description': 'The rate of the potential adverse events were monitored during the intervention.'}], 'primaryOutcomes': [{'measure': 'Endoscopic response rate', 'timeFrame': 'week12, week26, week52', 'description': 'The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.'}], 'secondaryOutcomes': [{'measure': 'Relative Change of Peak Eosinophil Counts in the Stomach', 'timeFrame': 'week12，week26，week52', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Eosinophilic Gastrointestinal Disorders (EGIDs)']}, 'descriptionModule': {'briefSummary': 'This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Refractory Peptic Ulcers\n* with Refractory Eosinophilic Gastrointestinal Disorders\n\nExclusion Criteria:\n\n* with Active Helicobacter pylori infection at present.\n* with Inflammatory bowel disease\n* with Parasite infection\n* with Cancer'}, 'identificationModule': {'nctId': 'NCT07257835', 'briefTitle': 'Dupilumab Therapy for EGIDs', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Dupilumab Therapy for Refractory Eosinophilic Gastrointestinal Disorders in Children', 'orgStudyIdInfo': {'id': 'Dupilumab in EGIDs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump', 'interventionNames': ['Drug: Dupilumab - Standard Dose', 'Device: subcutaneous injection']}], 'interventions': [{'name': 'Dupilumab - Standard Dose', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump']}, {'name': 'subcutaneous injection', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi-heng Huang', 'role': 'CONTACT', 'email': 'yhuang815@163.com', 'phone': '021-64931727'}], 'facility': '201102', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ying Huang', 'role': 'CONTACT', 'email': 'yhuang815@163.com', 'phone': '021-64931727'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of gastroenterology department', 'investigatorFullName': 'Ying HUANG', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}