A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Oral Budesonide Suspension (OBS); Placebo
Intervention description: Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.; Oral dose of 10 ml of placebo matched with the experimental drug.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 318.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the
      histologic response and determine if any reduction in dysphagia is achieved.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participants 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.

          -  Participant is male or female aged 11-55 years, inclusive, at time of consent.

          -  Participant has histologic evidence of eosinophilic esophagitis (EoE) with a peak
             eosinophil count of greater than or equal to (>=) 15/ high-powered field (HPF), from 2
             of 3 (proximal, mid-, and/or distal) levels of the esophagus at the screening
             endoscopy.

          -  Participant has a history of clinical symptoms of esophageal dysfunction (for example,
             eating problems, abdominal pain, heartburn, dysphagia, vomiting, food impaction,
             weight loss) intermittently or continuously at screening (Visit -1).

          -  Participants must have experienced dysphagia (response of "yes" to question 2 on
             Dysphagia Symptom Questionnaire [DSQ]) on a minimum of 4 days and completed the DSQ on
             >= 70 percent (%) of days in any 2 consecutive weeks of the screening period and in
             the last 2 weeks prior to the baseline visit (Visit 1).

          -  Participant must not have PPI-responsive EoE based on esophageal biopsies performed
             after the patient has been on at least 8 weeks of high-dose PPI therapy (high-dose
             therapy refers to the total daily dose, which may have been administered as a once or
             twice daily dosing regimen). This may occur at the time of the qualifying
             esophagogastroduodenoscopy (EGD) (in which case the same proton pump inhibitor (PPI)
             regimen must be continued), or this may have been done previously (in which case PPI
             therapy may have been stopped if there was no response to therapy based on esophageal
             biopsy results). If PPI responsiveness was excluded by a previous EGD and biopsy, the
             historical EGD and biopsy must have been performed after the patient had been on a
             minimum of 6 weeks of high-dose PPI therapy.

          -  Participant will be on a stable (no changes) diet >=3 months prior to the screening
             visit (Visit -1).

          -  Participant is willing and able to continue any dietary therapy, environmental
             therapy, and/or medical regimens (including gastric acid suppression) in effect at the
             screening visit (Visit -1). There should be no change to these regimens during study
             participation.

          -  All female participants 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 (for
             example, abstinence, 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 defined in this protocol.

        Exclusion Criteria

          -  Participant has any condition or abnormality (including laboratory abnormalities),
             current or past, that, in the opinion of the principal investigator or medical
             monitor, would compromise the safety of the participant or interfere with or
             complicate the assessment of signs or symptoms of EoE. Such conditions may include
             psychiatric problems; neurologic deficits or disease; developmental delay;
             cardiovascular, metabolic, or pulmonary disease; or previous gastroesophageal surgery.
             These should be discussed with the medical monitor.

          -  Participant has used immunomodulatory therapy within 8 weeks prior to the qualifying
             EGD or between the qualifying EGD and baseline visit (Visit 1) or anticipates using
             immunomodulatory therapy during the treatment period (except for any ongoing regimen
             of allergy shots). Use of long-acting immunomodulatory therapy (for example, Rituxan)
             within 3 months of the qualifying EGD should be reviewed with the medical monitor.

          -  Participant has been using swallowed topical corticosteroid for EoE or systemic
             corticosteroid for any condition within the 4 weeks prior to the qualifying EGD,
             between the qualifying EGD and baseline visit (Visit 1), or anticipates use 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 cannot occur within 4 weeks of the final EGD.

          -  Participant has been on inhaled steroids and has not been on stable treatment for >=3
             months prior to screening visit (Visit -1). Participants on inhaled steroids need to
             stay on a stable treatment during study participation. Participant has been on
             intranasal steroids and has not been on stable treatment for a minimum of 4 weeks
             prior to the qualifying EGD. After the qualifying EGD, participants with seasonal
             allergic rhinitis may resume (or discontinue) intranasal corticosteroids based on the
             participant's usual treatment regimen for allergy season.

          -  Participant has initiated, discontinued, or changed dosage regimen of PPIs, H2
             antagonists, antacids, or leukotriene inhibitors for any condition (such as
             gastroesophageal reflux disease, asthma or allergic rhinitis) within the 4 weeks prior
             to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or
             anticipates changes in the use of such medications during the treatment period.

          -  Participant has been using cytochrome P450 3A4 (CYP450 3A4) inhibitors (for example,
             ketoconazole, grapefruit juice) within the 2 weeks prior to the baseline visit (Visit
             1) or within 5 half-lives (whichever is greater) or anticipates using such medications
             during the treatment period.

          -  Participant has an appearance on qualifying 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 (for example, with an insertion tube diameter of
             greater than [>]9 millimeter [mm]).

          -  Participant is on a pure liquid diet or the 6-food elimination diet.

          -  Participant has had an esophageal dilation within the 3 months prior to screening
             (Visit -1).

          -  Participant has presence of esophageal varices at the screening endoscopy.

          -  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 EoE, including
             hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or
             parasitic infection.

          -  Participant has current evidence of oropharyngeal or esophageal candidiasis.

          -  Participant has a potentially serious acute or chronic viral infection or
             immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite
             infection, ocular herpes simplex, herpes esophagitis, or chicken pox/measles.

          -  Participant has upper gastrointestinal bleeding within 4 weeks prior to the screening
             visit (Visit - 1) or between the screening visit and baseline visit (Visit 1).

          -  Participant has evidence of active infection with Helicobacter pylori.

          -  Participant has evidence of unstable asthma within 4 weeks prior to the screening
             visit (Visit -1) and between the screening visit and baseline visit (Visit 1).

          -  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
             investigational product.

          -  Participant has taken part and received intervention in an interventional study
             related to EoE (except for an interventional study for a topical swallowed steroid)
             within 6 months prior to the screening visit (Visit -1), or any investigational study
             within 30 days prior to the screening visit (Visit -1). An investigational topical
             swallowed steroid must have been discontinued at least 30 days prior to the screening
             visit (Visit -1).

          -  Participant has a history or high risk of noncompliance with treatment or regular
             clinic visits.

          -  Participant has previously completed, discontinued, or withdrawn from this study.

          -  Participant has participated in a previous clinical study involving oral budesonide
             suspension (OBS) (SHP621).

          -  Participant anticipates using sucralfate during the study.