Clinical Trials

Inclusion Criteria:

•  Adult male or female ≥15 years of age at the time of informed consent or assent
• Each subject and/or their parents or legal guardian (for adolescents), must read, understand and provide consent or assent together with their parent(s) or guardian signature (for adolescents) on the ICF for this study and be willing and able to adhere to study-related treatment regimens, procedures and visit schedule
• Diagnosis or presumptive diagnosis of EoE that is confirmed during the Screening period by histology that demonstrates ≥15 peak eos/HPF. In order to ensure that a diagnosis can be made, at least 5-6 biopsies should be taken including both proximal and distal specimens (~3 each). Mid-esophageal biopsies are optional 1. Esophagogastroduodenoscopies and biopsies are to be obtained during the Screening period 2. Biopsies will be read by a central pathologist 3. Esophagogastroduodenoscopies and biopsies performed outside the study will not be accepted to meet eligibility criteria 4. Optional biopsies may be taken and processed locally for local use, if specified in the local ICF. If serious pathology is unexpectedly encountered biopsies of such lesions must be processed locally
• Addtional Inclusion Criteria may apply.

Exclusion Criteria:

• Have known contraindication, hypersensitivity, or intolerance to corticosteroids
• Have a contraindication to, or factors that substantially increase the risk of, EGD procedure or esophageal biopsy or have narrowing of the esophagus that precludes EGD with a standard 9 mm endoscope
• Have history of an esophageal stricture requiring dilatation within the 12 weeks prior to Screening
• Bone age more than 12 months behind chronological age for adolescent subjects
• Have any physical, mental, or social condition or history of illness or laboratory abnormality that in the Investigator's judgment might interfere with study procedures or the ability of the subject to adhere to and complete the study or increase the safety risk to the subject such as uncontrolled diabetes or hypertension or may increase risk of corticosteroid toxicity (e.g. abnormal bone mineral density)
• History or presence of oral or esophageal mucosal infection whilst using inhaled or nasal corticosteroids
• Have any mouth or dental condition that prevents normal eating (excluding braces)
• Have any condition affecting the esophageal mucosa or altering esophageal motility other than EoE, including erosive esophagitis (grade B or higher as per the Los Angeles Classification of Gastroesophageal Reflux Disease;19, hiatus hernia longer than 3 cm, Barrett's esophagus, and achalasia)
• Use of systemic (oral or parenteral) corticosteroids within 60 days before Screening, use of swallowed corticosteroids within 30 days before Screening
• Initiation of either inhaled or nasal corticosteroids or high-potency dermal topical corticosteroids within 30 days before Screening
• Use of calcineurin inhibitors or purine analogues (azathioprine, 6-mercaptopurine) in the 12 weeks before Screening
• Use of potent cytochrome P450 (CYP) 3A4 inhibitors (eg, ritonavir and ketoconazole) in the 12 weeks before Screening
• Initiation of an elimination diet or elemental diet within 30 days before Screening (diet must remain stable after signing ICF)
• Morning (07:00 to 09:00, or as close to that window as possible) serum cortisol level ≤5 μg/dL (138 nmol/L) that is not responsive to ACTH stimulation: defined as a serum cortisol level <16 μg/dL (440 nmol/L) at 60 minutes with ACTH stimulation test using 250 μg cosyntropin administered intramuscularly (ie, an abnormal result on the ACTH stimulation test)
• Additional Exclusion Criteria may apply.