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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:11 - 55
Updated:3/15/2019
Start Date:October 5, 2017
End Date:April 30, 2021
Contact:Shire Contact
Email:ClinicalTransparency@shire.com
Phone:1 866-842-5335

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

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.


Inclusion Criteria:

- Subject completed the SHP621-302 (NCT02736409) extension study and is considered by
the investigator to potentially benefit from continued BOS investigational treatment.

- Subject is able to provide written informed consent (subject, parent or legal guardian
and, as appropriate, subject 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 (eg): abstinence, surgically sterile male partner, stable oral
contraceptives, or double-barrier methods) throughout study participation.

- Subject is willing and has an understanding and ability to fully comply with study
procedures and restrictions as defined in protocol.

Exclusion Criteria:

- Subject has changes in medications or diet during the SHP621-302 (NCT02736409) study
that could affect participation in this continuation study.

- Subject 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).

- Subject anticipates use of Cytochrome P450 3A4 inhibitors (eg, ketoconazole,
grapefruit juice) during the continuation study.

- Subject 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 (eg, with an insertion tube diameter of greater than (>) 9 millimeter [mm]).

- Subject has presence of esophageal varices at the EGD at the final treatment
evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.

- Subject has any current disease of the gastrointestinal tract, aside from EoE,
including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatory bowel
disease, or celiac disease.

- Subject has other diseases causing or associated with esophageal eosinophilia,
including hypereosinophilic syndrome, collagen vascular disease, vasculitis,
achalasia, or parasitic infection.

- Subject 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 subject is expected to respond to treatment.

- Subject 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.

- Subject has upper gastrointestinal bleeding identified at the EGD at the final
treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.

- Subject has evidence of active infection with Helicobacter pylori.

- Subject has evidence of unstable asthma.

- Subject is female and pregnant or nursing.

- Subject has a history of intolerance, hypersensitivity, or idiosyncratic reaction to
budesonide (or any other corticosteroids), or to any other ingredients of the study
medication.

- Subject has a history or high risk of noncompliance with treatment or regular clinic
visits
We found this trial at
28
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Baton Rouge, Louisiana 70809
Principal Investigator: Satyaprasad Alapati, MD
Phone: 225-927-1190
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: John Leung, MD
Phone: 617-636-2379
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Evan Dellon, MD
Phone: 919-966-7957
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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610 3rd St # 206
Macon, Georgia 31201
Principal Investigator: Shahriar Sedghi, MD
Phone: 478-464-2600
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: Yamen Smadi, MD
Phone: 321-841-1077
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
Principal Investigator: Curtis Baum, MD
Phone: 785-270-8604
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Atlanta, Georgia 30342
Principal Investigator: Benjamin Gold, MD
Phone: 404-503-2279
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Aurora, Colorado 80045
Principal Investigator: Calies Menard-Katcher, MD
Phone: 720-777-2797
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Bristol, Connecticut 06010
Principal Investigator: Salam Zakko, MD
Phone: 860-585-3838
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Charlotte, North Carolina 28277
Principal Investigator: Douglas Johnston, DO
Phone: 980-999-2054
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Ikuo Hirano, MD
Phone: 312-695-4036
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Vidhya Kunnathur, MD
Phone: 513-584-2363
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2709 North Tejon Street
Colorado Springs, Colorado 80907
Principal Investigator: Daniel Soteres, MD
Phone: 719-473-0872
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Dayton, Ohio 45415
Principal Investigator: Steven Dellon, MD
Phone: 937-320-5050
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Farmington, Connecticut 06032
Principal Investigator: David Chaletsky, MD
Phone: 860-409-4567
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Great Neck, New York 11023
Principal Investigator: MIchael Goldstein, MD
Phone: 516-482-5976
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Houston, Texas 77079
Principal Investigator: Vikram Jayanty, MD
Phone: 713-932-6446
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Iowa City, Iowa 52242
Principal Investigator: Yehudith Assouline-Dayan, MD
Phone: 319-356-7209
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Lansdowne Town Center, Virginia 20176
Principal Investigator: Satinder Gill, MD
Phone: 703-723-3670
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Lone Tree, Colorado 80124
Principal Investigator: Theodore Stathos, MD
Phone: 303-790-1515
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Louisville, Kentucky 40202
Principal Investigator: John Wo, MD
Phone: 317-948-9227
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Lynchburg, Virginia 24502
Principal Investigator: Larry Clark Jr., MD
Phone: 434-455-8670
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Mentor, Ohio 44060
Principal Investigator: Keith Friedenberg, MD
Phone: 440-205-1225
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2630 Grant Line Road
New Albany, Indiana 47150
Principal Investigator: Steven Harrell, MD
Phone: 812-206-1702
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North Little Rock, Arkansas
Principal Investigator: Robert Murphy, MD
Phone: 501-945-9300
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Ogden, Utah 84405
Principal Investigator: John Lowe, MD
Phone: 801-409-2040
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Salt Lake City, Utah 84143
Principal Investigator: Molly O'Gorman, MD
Phone: 801-587-7484
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Tucson, Arizona 85710
Principal Investigator: Gary Gottlieb, MD
Phone: 520-257-3881
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