Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
NCT ID: NCT03245840
Last Updated: 2025-02-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
133 participants
INTERVENTIONAL
2017-10-05
2022-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Budesonide Oral Suspension
Participants received 10 milliliters (mL) of budesonide oral suspension at a concentration of 0.2 milligram per milliliter (mg/mL), twice daily, for up to 4 years 5 months.
Budesonide oral suspension
BOS 10 mL twice daily.
Interventions
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Budesonide oral suspension
BOS 10 mL twice daily.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
11 Years
55 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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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
Brigham and Womens Hospital
Chestnut Hill, Massachusetts, United States
Minnesota Gastroenterology PA
Plymouth, Minnesota, United States
Mount Sinai Hospital, Icahn School of Medicine
Astoria, New York, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Gastrointestinal and Liver Diseases Consultants PC
Dayton, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States
Greenville Hospital
Greenville, South Carolina, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Endoscopy and Research Center
Houston, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Primary Children's Hospital, University of Utah
Salt Lake City, Utah, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Countries
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References
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Dellon ES, Katzka DA, Mukkada VA, Collins MH, Falk GW, Richmond CA, Terreri B, Thakur M, Boules M, Goodwin B, Hirano I. Long-term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: A 4-Year, Phase 3, Open-Label Study. Clin Gastroenterol Hepatol. 2025 Feb 13:S1542-3565(25)00118-1. doi: 10.1016/j.cgh.2024.12.024. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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SHP621-303
Identifier Type: -
Identifier Source: org_study_id
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