Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.

Ki vehet részt

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged ≥18 year of age at Mayo Clinic Rochester or Mayo Clinic Scottsdale at time of informed consent
• Have a documented diagnosis of EoE per standard guidelines
• Have histologically active EoE (defined as a peak eosinophil count >15 eosinophils per high-power field; eos/hpf)
• Weight ≥40 kg
• Ability to take injectable or oral medication and be willing to adhere to the study intervention regimen
• 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
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
• Subject agrees to maintain a stable diet
• Subject is willing to receive weekly injections throughout the study
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements

Ki nem vehet részt

• Prior esophageal surgery, coagulopathy or esophageal varices
• Use of prednisone within 2 months prior to study enrollment
• Treatment with biologic therapies for other disease indications
• Treatment with medium or high potency topical steroids for skin conditions
• Known allergic reactions to components of dupilumab or budesonide suspension
• Non-EoE eosinophilic GI diseases (EGIDs) or hypereosinophilic disorders
• Known achalasia, crohn's disease, ulcerative colitis, celiac disease
• Child-Pugh Class C liver disease
• Autoimmune conditions including lupus, rheumatoid arthritis and psoriatic arthritis
• 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
• Inability to provide informed consent
• Pregnancy or lactation
• Contraindication to performing upper endoscopy
• Failed dupilumab
• Failed swallowed topical budesonide
• Erosive esophagitis LA B and above found during EGD