Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)

Inclusion Criteria:

• Participant completed the SHP621-302 (NCT02736409) extension study and is consideredby the investigator to potentially benefit from continued BOS investigationaltreatment.

• Participant is able to provide written informed consent (participant, parent orlegal guardian and, as appropriate, participant assent) to participate in the studybefore completing any study-related procedures.

• Females of childbearing potential must agree to continue acceptable birth controlmeasures (example (e.g.): abstinence, surgically sterile male partner, stable oralcontraceptives, or double-barrier methods) throughout study participation.

• Participant is willing and has an understanding and ability to fully comply withstudy 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 systemiccorticosteroid for any condition during the treatment period; any temporary use (less than or equal to [≤] 7 days) or initiation of new steroid treatment during thestudy should be documented and discussed with the medical monitor prospectively butshould 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 ofSHP621-302 (NCT02736409) (Visit 8) of an esophageal stricture (high grade), asdefined by the presence of a lesion that does not allow passage of a diagnosticadult upper endoscope (e.g., with an insertion tube diameter of greater than (>) 9millimeter [mm]).

• Participant has presence of esophageal varices at the EGD at the final treatmentevaluation 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, inflammatorybowel 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 toprevious treatment. Diagnosis with oropharyngeal or esophageal candidiasis at orsince 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 totreatment.

• Participant has a potentially serious acute or chronic infection or immunodeficiencycondition, 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 finaltreatment 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 idiosyncraticreaction to budesonide (or any other corticosteroids), or to any other ingredientsof the study medication.

• Participant has a history or high risk of noncompliance with treatment or regularclinic visits.