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

Stopped early · Phase 3

Conditions studied: Eosinophilic Esophagitis (EoE)

In brief

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.

Key facts

Study ID

NCT03245840

Run by

Shire

People needed

133

Starts

2017-10-05

Expected to finish

2022-04-26

Last updated by the study team

2025-02-19

Who can join

Age: 11 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital — Birmingham, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Del Sol Research Management — Tucson, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Colorado Children's Hospital — Aurora, Colorado, United States
• Asthma and Allergy Associates PC — Colorado Springs, Colorado, United States
• Rocky Mountain Pediatric Gastroenterology — Denver, Colorado, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Connecticut GI — Hartford, Connecticut, United States
• Nature Coast Clinical Research LLC — Inverness, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Childrens Center For Digestive Healthcare — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Grand Teton Research Group — Idaho Falls, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Gastroenterology of Southern Indiana — New Albany, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• Indiana University — Louisville, Kentucky, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Clinical Trials Management LLC — Metairie, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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