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De klinische studie NCT07358234 voor Eosinofiele oesofagitis (EoE) is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis. Vroege fase 1 60

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De klinische studie NCT07358234 onderzoekt behandeling bij Eosinofiele oesofagitis (EoE). Deze Vroege fase 1 interventioneel studie heeft de status nog niet rekruterend. De inclusie van 60 deelnemers begint op 1 februari 2026. De studie wordt geleid door Mayo Kliniek en de voltooiing is gepland op 1 december 2027. Laatste update op ClinicalTrials.gov: 22 januari 2026.
Beknopte samenvatting
The purpose of this study is to compare Eosinophilic Esophagitis treatments Eohilia with Dupixent in their effects on diameter and scarring of the esophagus.
Uitgebreide beschrijving
Eosinophilic esophagitis (EoE) is a chronic disease mediated by environmental allergens and type 2 immune inflammation which causes significant symptoms, food impactions, and stenosis. EoE is associated with significant esophageal stricturing disease. In particular, the odds of developing fibrostenotic disease in EoE more than double per decade of life, and the longer symptoms are present prior to diagnosis and treat...Toon meer
Officiële titel

Prospective Trial Comparing Swallowed Topical Budesonide With Subcutaneous Dupilumab on Esophageal Diameter and Fibrotic Change in Eosinophilic Esophagitis

Aandoeningen
Eosinofiele oesofagitis (EoE)
Andere studie-ID's
  • 25-005776
NCT-ID
NCT07358234
Startdatum (Werkelijk)
2026-02
Laatste update geplaatst
2026-01-22
Verwachte einddatum
2027-12
Inschrijving (Geschat)
60
Studietype
Interventioneel
FASE
Vroege fase 1
Status
Nog niet rekruterend
Trefwoorden
dupilumab
budesonide oral suspension
Eohilia
Dupixent
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorbudesonide oral suspension (Eohilia)
2mg twice daily
budesonide oral suspension
2mg twice daily
Actieve comparatordupilumab (Dupixent)
300 mg weekly injection
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
300 mg weekly injection
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Esophageal diameter
the minimum esophageal diameter after 12 weeks of treatment.
from enrollment until up to 14 weeks
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Distensibility and diameter change
Secondary outcomes will include distensibility and change in minimum diameter as measured by endoFLIP topography
from baseline to end of treatment at 14 weeks
EEsAI questionnaire scores
comparison of questionnaires that are scored 0-100 before and after treatment.
from enrollment to the end of treatment at 12 weeks
Endoscopic refernece score (EREFS)
comparison of EREFs scores on scale of 0-9 at EGDs
from enrollment up to end of treatment at 12 weeks
Eosinophil counts
number of eosinophils found in biopsy during EGD
from enrollment to the end of treatment at 12 weeks
Eoe Histologic Scoring system (EoEHSS)
An EoEHSS score is given by looking at a biopsy taken during an endoscopy. The score is based on observation of the appearance of the biopsy under a microscope. Score range is 0 to 1
from enrollment to end of treatment at 12 weeks
M2 macrophage polarization
comparison of myofibroblast differentiation
from enrollment to end of treatment at 12 weeks
Lamina propria remodeling
characterizing Lamina propria remodeling by second harmonic imaging microscopy
from enrollment to end of treatment at week 12
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged ≥18 year of age at Mayo Clinic Rochester or Mayo Clinic Scottsdale at time of informed consent
  4. Have a documented diagnosis of EoE per standard guidelines
  5. Have histologically active EoE (defined as a peak eosinophil count >15 eosinophils per high-power field; eos/hpf)
  6. Weight ≥40 kg
  7. Ability to take injectable or oral medication and be willing to adhere to the study intervention regimen
  8. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 12 weeks after the end of dupilumab or budesonide suspension administration. Willingness to complete pregnancy tests during study visits and at end of study.
  9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
  10. Subject agrees to maintain a stable diet
  11. Subject is willing to receive weekly injections throughout the study
  12. Subject is willing and able to adhere to the study visit schedule and other protocol requirements

  1. Inability to provide informed consent
  2. Pregnancy or lactation
  3. Contraindication to performing upper endoscopy
  4. Known allergic reactions to components of dupilumab or budesonide suspension
  5. Non-EoE eosinophilic GI diseases (EGIDs) or hypereosinophilic disorders
  6. Prior esophageal surgery, coagulopathy or esophageal varices
  7. Known achalasia, crohn's disease, ulcerative colitis, celiac disease
  8. Child-Pugh Class C liver disease
  9. Failed dupilumab
  10. Failed swallowed topical budesonide
  11. Erosive esophagitis LA B and above found during EGD
  12. Use of prednisone within 2 months prior to study enrollment
  13. Treatment with biologic therapies for other disease indications
  14. Treatment with medium or high potency topical steroids for skin conditions
  15. Autoimmune conditions including lupus, rheumatoid arthritis and psoriatic arthritis
  16. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
Mayo Clinic logoMayo Kliniek861 actieve klinische studies om te verkennen
Vanderbilt University Medical Center logoVanderbilt Universiteit
Verantwoordelijke instantie
Diana L. Snyder, Hoofdonderzoeker, Principal Investigator, Mayo Clinic
Centraal Contactpersoon
Contact: Mariah J Robran, 507-266-3595, [email protected]
Contact: Alexandria Ramirez, 480-574-1853, [email protected]
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