Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

Inclusion Criteria

• •1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
• •2. Weight ≥ 40 kg at Visit 1
• •3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
• •4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1.
• •5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study (stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups).
• •6. May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period.
• •7. Participants currently on leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).
• •8. If a medication for EoE (for example PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer.
• •9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.