Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Budesonide oral suspension
Intervention description: BOS 10 mL twice daily.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This is a continuation study of Budesonide Oral Suspension (BOS) in adults and adolescents
      with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-302
      extension study. The purpose of this study is to see if BOS is safe and well tolerated over
      the long-term in adolescents and adults with EoE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant completed the SHP621-302 (NCT02736409) extension study and is considered
             by the investigator to potentially benefit from continued BOS investigational
             treatment.

          -  Participant is able to provide written informed consent (participant, parent or legal
             guardian and, as appropriate, participant assent) to participate in the study before
             completing any study-related procedures.

          -  Females of childbearing potential must agree to continue acceptable birth control
             measures (example (e.g.): abstinence, surgically sterile male partner, stable oral
             contraceptives, or double-barrier methods) throughout study participation.

          -  Participant is willing and has an understanding and ability to fully comply with study
             procedures and restrictions as defined in protocol.

        Exclusion Criteria:

          -  Participant has changes in medications or diet during the SHP621-302 (NCT02736409)
             study that could affect participation in this continuation study.

          -  Participant anticipates using swallowed topical corticosteroid for EoE or systemic
             corticosteroid for any condition during the treatment period; any temporary use (less
             than or equal to [≤] 7 days) or initiation of new steroid treatment during the study
             should be documented and discussed with the medical monitor prospectively but should
             be avoided within 4 weeks of the scheduled esophagogastroduodenoscopy (EGDs).

          -  Participant anticipates use of Cytochrome P450 3A4 inhibitors (e.g., ketoconazole,
             grapefruit juice) during the continuation study.

          -  Participant has an appearance at the EGD at the final treatment evaluation visit of
             SHP621-302 (NCT02736409) (Visit 8) 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 (e.g., with an insertion tube diameter of greater than (>) 9 millimeter
             [mm]).

          -  Participant has presence of esophageal varices at the EGD at the final treatment
             evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.

          -  Participant has any current disease of the gastrointestinal tract, aside from EoE,
             including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel
             disease, or celiac disease.

          -  Participant has other diseases causing or associated with esophageal eosinophilia,
             including hypereosinophilic syndrome, collagen vascular disease, vasculitis,
             achalasia, or parasitic infection.

          -  Participant 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 8) of the SHP621-302 (NCT02736409) study
             is not an exclusion as long as the participant is expected to respond to treatment.

          -  Participant has a potentially serious acute or chronic infection or immunodeficiency
             condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular
             herpes simplex, or chicken pox/measles.

          -  Participant has upper gastrointestinal bleeding identified at the EGD at the final
             treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.

          -  Participant has evidence of active infection with Helicobacter pylori.

          -  Participant has evidence of unstable asthma.

          -  Participant is female and pregnant or nursing.

          -  Participant has a history of intolerance, hypersensitivity, or idiosyncratic reaction
             to budesonide (or any other corticosteroids), or to any other ingredients of the study
             medication.

          -  Participant has a history or high risk of noncompliance with treatment or regular
             clinic visits.