An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Oral Budesonide Suspension (OBS); Placebo
Intervention description: OBS 2mg twice daily; Matching Placebo dose
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 219.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in
      adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE)
      who have completed participation in the SHP621-301 induction study (NCT02605837). The primary
      objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of
      efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire
      (DSQ) score.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject completed SHP621-301 induction study.

          2. Subject is able to provide written informed consent (subject, parent or legal guardian
             and, as appropriate, subject assent) to participate in the study before completing any
             study-related procedures.

          3. Subject is male or female aged 11-55 years, inclusive, at time of consent for
             SHP621-301 study.

          4. Subject is willing and able to continue any dietary therapy, environmental therapy,
             and/or medical regimens (including gastric acid suppression; see exclusions below) in
             effect at the screening visit (Visit 0). There should be no changes to these regimens
             during study participation.

          5. All female subjects must have a negative serum pregnancy test (beta-human chorionic
             gonadotropin [β-hCG]) prior to enrollment into the study. Females of childbearing
             potential must agree to continue acceptable birth control measures (eg, abstinence,
             stable oral contraceptives, or double-barrier methods) throughout study participation
             and for 30 days following the last dose of investigational product.

          6. Subject is willing and has an understanding and ability to fully comply with study
             procedures including DSQ compliance (completed the DSQ on ≥70% of days in any 2
             consecutive weeks of the screening period)and restrictions defined in this protocol

        Exclusion Criteria:

          1. Subject has changes in medications that could affect the study or diet in the weeks
             since the final treatment evaluation visit (Visit 4) of the SHP621-301 study.

          2. Subject using immunomodulatory therapy since the final treatment evaluation visit
             (Visit 4) of the SHP621-301 study or anticipated use of immunomodulatory therapy
             during the treatment period (except for any ongoing regimen of allergy shots); any
             temporary use (≤7 days) or initiation of new steroid treatment during the study should
             be documented and discussed with the medical monitor prospectively but cannot occur
             within 4 weeks of scheduled EGDs.

          3. Subject using swallowed topical corticosteroid for EoE or systemic corticosteroid for
             any condition since the final treatment evaluation visit (Visit 4) of the SHP621-301
             study or anticipated use during the treatment period; any temporary use (≤7 days) or
             initiation of new steroid treatment during the study should be documented and
             discussed with medical monitor prospectively but cannot occur within the 4 weeks of
             the scheduled EGDs.

          4. Subject on inhaled or intranasal steroids and not on a stable dose between the
             baseline visit (Visit 1) of the SHP621-301 study and the screening EGD of this study.

          5. Subject has initiated, discontinued, or changed dosage regimen of proton pump
             inhibitors (PPIs), H2 antagonists, antacids, antihistamines, or leukotriene inhibitors
             for any condition (such as gastroesophageal reflux disease, asthma or allergic
             rhinitis) since the final treatment evaluation visit (Visit 4) of the SHP621-301 study
             or anticipated changes in the use of such medications during the treatment period.

          6. Subject using Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice)
             since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or
             anticipated use of such medications during the treatment period.

          7. Subject has an appearance on screening EGD of an esophageal stricture (high grade), as
             defined by the presence of a lesion that does not allow passage of a diagnostic adult
             upper endoscope (eg, with an insertion tube diameter of >9mm).

          8. Subject is on a pure liquid diet or the six-food elimination diet.

          9. Subject has presence of esophageal varices at the EGD at the final treatment
             evaluation visit (Visit 4) of the SHP621-301 study.

         10. Subject has any current disease of the gastrointestinal tract, aside from EoE,
             including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel
             disease, or celiac disease.

         11. Subject has other diseases causing or associated with esophageal eosinophilia,
             including hypereosinophilic syndrome, collagen vascular disease, vasculitis,
             achalasia, or parasitic infection.

         12. Subject has oropharyngeal or esophageal candidiasis that failed to respond to previous
             treatment.

             Diagnosis with oropharyngeal or esophageal candidiasis at or since the final treatment
             evaluation visit (Visit 4) of the SHP621-301 study is not an exclusion as long as the
             subject received treatment for candidiasis and is expected to respond to treatment.

         13. Subject has acute or chronic infection or immunodeficiency condition, including
             tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, or
             chicken pox/measles.

         14. Subject has upper gastrointestinal bleeding identified in the EGD at the final
             treatment evaluation visit (Visit 4) of the SHP621-301 study or since the final
             treatment evaluation visit (Visit 4) of the SHP621-301 study.

         15. Subject has evidence of active infection with Helicobacter pylori.

         16. Subject has evidence of unstable asthma since the final treatment evaluation visit
             (Visit 4) of the SHP621-301 study.

         17. Subject is female and pregnant or nursing.

         18. Subject has a history of intolerance, hypersensitivity, or idiosyncratic reaction to
             budesonide (or any other corticosteroids), or to any other ingredients of the study
             medication.

         19. Subject has a history or high risk of noncompliance with treatment or regular clinic
             visits.

         20. Subject is on sucralfate or anticipates using sucralfate during the treatment period.