Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: budesonide; placebo
Intervention description: oral suspension; oral suspension matching budesonide
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: eosinophilic esophagitis

Summary:

      This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with
      eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of
      four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit
      the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for
      clinical symptom assessment and safety evaluation (including adverse events and vital signs).
      All study treatments (active drug and placebo) will be administered orally twice daily during
      the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between the ages of 2-18 years, inclusive

          -  History of clinical symptoms of esophageal dysfunction intermittently or continuously

          -  Histologic evidence of EoE with a peak eosinophil count of greater than or equal to 20
             eosinophils per HPF, from two or more levels of the esophagus, within six weeks prior
             to the Baseline Visit

          -  At the Baseline Visit, subjects must have symptoms with a total EoE Clinical Symptom
             Score of greater than or equal to 3

          -  Willingness and ability to continue the dietary therapy, environmental therapy, and/or
             medical regimens (including gastric acid suppression, if any) in effect at the
             Screening Visit

          -  Females of childbearing potential must have a negative serum pregnancy test (beta
             human chorionic gonadotropin) prior to randomization into the study and sexually
             active subjects must agree to continue acceptable birth control measures throughout
             the duration of the study

          -  Written informed consent (parent or legal guardian) and, as appropriate, subject
             assent

        Exclusion Criteria:

          -  Current use of immunomodulatory therapy (or anticipated use within 12 weeks following
             the Baseline Visit)

          -  Diagnosis of inflammatory bowel disease

          -  Chronic viral infection or immunodeficiency condition (current)

          -  Use of swallowed topical corticosteroids for EoE in the 1 month prior to the biopsy
             required for entrance to this study or at any time between the biopsy and the Baseline
             Visit

          -  Use of systemic (oral or parenteral) corticosteroid within 1 month prior to the biopsy
             required for entrance to this study or at any time between the biopsy and the Baseline
             Visit

          -  Morning plasma cortisol level below the lower limit of normal (per Central Laboratory
             reference range) at the Screening Visit

          -  Upper gastrointestinal bleeding within 1 month prior to the Screening Visit or between
             the Screening Visit and Baseline Visit

          -  Current use of anticoagulants

          -  Current disease of the gastrointestinal tract aside from the current EoE diagnosis

          -  Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis

          -  Evidence of active infection with Helicobacter pylori

          -  Evidence of unstable asthma or changes in asthma or allergic rhinitis therapy within 1
             month prior to the biopsy required for entrance to this study

          -  Any female who is pregnant, who is planning to become pregnant, or who is
             breast-feeding

          -  Current evidence or history of hypersensitivity or idiosyncratic reaction to
             budesonide or any other ingredients of the study medication

          -  Current evidence of oropharyngeal or esophageal candidiasis

          -  Receipt of an investigational drug within 30 days prior to the biopsy required for
             entrance to this study

          -  Any condition or abnormality that, in the opinion of the Principal Investigator, would
             compromise the safety of the subject or successful conduct of the study