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

Eosinophilic Esophagitis (EoE) Clinical Trial

Official title:

A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03245840
• Other study ID #: SHP621-303
• Status: Terminated
• Phase: Phase 3
• Start date: October 5, 2017
• Est. completion date: April 26, 2022

Study information

• Verified date: November 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Eosinophilic Esophagitis (EoE)
• Esophagitis

Intervention

Drug:
• Budesonide oral suspension
BOS 10 mL twice daily.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital, Icahn School of Medicine	Astoria	New York
United States	Childrens Center For Digestive Healthcare	Atlanta	Georgia
United States	Colorado Children's Hospital	Aurora	Colorado
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Children's Hospital	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Connecticut Clinical Research Foundation	Bristol	Connecticut
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Clinical Research of Charlotte	Charlotte	North Carolina
United States	Brigham and Womens Hospital	Chestnut Hill	Massachusetts
United States	Northwestern University	Chicago	Illinois
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	Asthma and Allergy Associates PC	Colorado Springs	Colorado
United States	Gastrointestinal and Liver Diseases Consultants PC	Dayton	Ohio
United States	Rocky Mountain Pediatric Gastroenterology	Denver	Colorado
United States	Gastro One	Germantown	Tennessee
United States	Long Island Gastrointestinal Research Group LLP	Great Neck	New York
United States	Greenville Hospital	Greenville	South Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Connecticut GI	Hartford	Connecticut
United States	Houston Endoscopy and Research Center	Houston	Texas
United States	Grand Teton Research Group	Idaho Falls	Idaho
United States	Nature Coast Clinical Research LLC	Inverness	Florida
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Emeritas Research Group	Lansdowne Town Center	Virginia
United States	Indiana University	Louisville	Kentucky
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	Great Lakes Gastroenterology	Mentor	Ohio
United States	Clinical Trials Management LLC	Metairie	Louisiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Gastroenterology of Southern Indiana	New Albany	Indiana
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Advanced Research Institute	Ogden	Utah
United States	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma
United States	Arnold Palmer Hospital for Children	Orlando	Florida
United States	Phoenix Childrens Hospital	Phoenix	Arizona
United States	Minnesota Gastroenterology PA	Plymouth	Minnesota
United States	Primary Children's Hospital, University of Utah	Salt Lake City	Utah
United States	Rady Children's Hospital San Diego	San Diego	California
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Del Sol Research Management	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Shire	Takeda Development Center Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. Both serious and Non-serious TEAEs were reported in this outcome measure. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose.	From start of study drug administration up to End of study (EOS) (Up to Month 53)
Primary	Number of Participants With Clinically Significant Physical Examination Findings	Number of participants with clinically significant physical examination findings were reported. Clinical significance was determined by investigator.	From start of study drug administration up to EOS (Up to Month 53)
Primary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Participants were assessed by investigator for any clinically significant changes in vital parameters like temperature, systolic and diastolic blood pressure, pulse, respiratory rate, BMI, and weight. Vital signs were assessed after the participant had been in a supine position for at least 5 minutes immediately prior to the assessment. The criteria for clinically significant change was as per the investigators discretion.	From start of study drug administration up to EOS (Up to Month 53)
Primary	Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Month 12	The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is less than (<) -2, suggesting a worse outcome (i.e., osteoporosis). Change from baseline in BMD for adolescents assessed by DXA Scan at Month 12 was reported.	Baseline, Month 12
Primary	Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 24	The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is <-2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at Month 24 was reported.	Baseline, Month 24
Primary	Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 36	The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is < -2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at Month 36 was reported.	Baseline, Month 36
Primary	Change From Baseline in BMD For Adolescents Assessed by DXA Scan at Month 48	The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is < -2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at Month 48 was reported.	Baseline, Month 48
Primary	Change From Baseline in BMD For Adolescents Assessed by DXA Scan at EOS (Up to Month 53)	The sites for DXA measurement were the lumbar spine at lumbar vertebrae 1 to 4 (L1-L4) and whole body. DXA scans for determination of BMD and body composition was performed in participants aged 11-17 years. Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. In this study, the BMD Z-score is considered abnormal when the z-score is < -2, suggesting a worse outcome (i.e., osteoporosis) and vice versa. Change from baseline in BMD for adolescents assessed by DXA Scan at EOS (up to Month 53) was reported.	Baseline, EOS (Up to Month 53)
Primary	Change From Baseline in Cortisol Level After Adrenocorticotropic Hormone (ACTH) Stimulation at Month 12	ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at Month 12 and reported in this outcome measure.	Baseline, Month 12
Primary	Change From Baseline in Cortisol Level After ACTH Stimulation at Month 24	ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at Month 24 and reported in this outcome measure.	Baseline, Month 24
Primary	Change From Baseline in Cortisol Level After ACTH Stimulation at Month 36	ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at Month 36 and reported in this outcome measure.	Baseline, Month 36
Primary	Change From Baseline in Cortisol Level After ACTH Stimulation at Month 48	ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at Month 48 and reported in this outcome measure.	Baseline, Month 48
Primary	Change From Baseline in Cortisol Level After ACTH Stimulation at EOS (Up to Month 53)	ACTH testing was a standard procedure to measure the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]). The type of synthetic and route of administration was per investigator discretion. The change from baseline in cortisol levels was calculated at EOS (up to Month 53) and reported in this outcome measure.	Baseline, EOS (Up to Month 53)
Primary	Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments	Clinical laboratory parameters included hematology, chemistry, urinalysis; urine pregnancy test. Number of participants with potential clinically significant changes in laboratory parameters which were deemed clinically meaningful by the investigator were reported.	From start of study drug administration up to EOS (Up to Month 53)

External Links

•   To obtain more information on the study, click here/on this link