Clinical trial NCT03245840: Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
Official title: A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Eosinophilic Esophagitis (EoE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2017-08-10
Enrollment: 133
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From start of study drug administration up to End of study (EOS) (Up to Month 53)
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: From start of study drug administration up to EOS (Up to Month 53)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: From start of study drug administration up to EOS (Up to Month 53)
measure: Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 48
timeFrame: Baseline, Month 48
measure: Change From Baseline in BMD For Adolescents Assessed by DXA Scan at EOS (Up to Month 53)
timeFrame: Baseline, EOS (Up to Month 53)
measure: Change From Baseline in Cortisol Level After Adrenocorticotropic Hormone (ACTH) Stimulation at Month 12
timeFrame: Baseline, Month 12
measure: Change From Baseline in Cortisol Level After ACTH Stimulation at Month 24
timeFrame: Baseline, Month 24
measure: Change From Baseline in Cortisol Level After ACTH Stimulation at Month 36
timeFrame: Baseline, Month 36
measure: Change From Baseline in Cortisol Level After ACTH Stimulation at Month 48
timeFrame: Baseline, Month 48
measure: Change From Baseline in Cortisol Level After ACTH Stimulation at EOS (Up to Month 53)
timeFrame: Baseline, EOS (Up to Month 53)
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
timeFrame: From start of study drug administration up to EOS (Up to Month 53)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Aurora
country: United States
facility: Colorado Children's Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates PC
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Pediatric Gastroenterology
state: Colorado
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
state: Connecticut
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Hartford
country: United States
facility: Connecticut GI
state: Connecticut
city: Inverness
country: United States
facility: Nature Coast Clinical Research LLC
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Atlanta
country: United States
facility: Childrens Center For Digestive Healthcare
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New Albany
country: United States
facility: Gastroenterology of Southern Indiana
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Louisville
country: United States
facility: Indiana University
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: Minnesota Gastroenterology PA
state: Minnesota
city: Astoria
country: United States
facility: Mount Sinai Hospital, Icahn School of Medicine
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Clinical Research of Charlotte
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal and Liver Diseases Consultants PC
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Greenville
country: United States
facility: Greenville Hospital
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital, University of Utah
state: Utah
city: Lansdowne Town Center
country: United States
facility: Emeritas Research Group
state: Virginia
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: