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

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ClinicalTrials.gov Identifier: NCT03245840
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis (EoE) Drug: Budesonide oral suspension Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Budesonide Oral Suspension
Participants will be initiated on 10 milliliter (mL) of Budesonide oral suspension (0.2 milligram/mL) twice daily up to 48 months (Visit 8) or early termination (ET).
Drug: Budesonide oral suspension
Budesonide oral suspension (BOS) 10 mL twice daily




Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration to 3 days after last study drug administration (up to Month 48) ]
    Treatment-emergent adverse event is defined as an adverse event (AE) that starts or deteriorates on or after the date of the first dose of BOS and no later than 3 days following the last dose of investigational product.

  2. Number of Participants With Clinically Relevant Changes in Physical Examinations, Vital Signs and Clinical Laboratory Assessments [ Time Frame: From start of study drug administration to 3 days after last study drug administration (up to Month 48) ]
    A change in the value of a clinical laboratory or vital sign assessment can represent an AE if the change is clinically relevant.

  3. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 2 (Month 12) [ Time Frame: Baseline and Visit 2 (Month 12) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  4. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 4 (Month 24) [ Time Frame: Baseline and Visit 4 (Month 24) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  5. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 6 (Month 36) [ Time Frame: Baseline and Visit 6 (Month 36) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  6. Change From Baseline in Bone Mineral Density (BMD) For Adolescents Assessed by Dual-Energy X-ray Absorptiometry (DXA) Scan at Visit 8 (Month 48) [ Time Frame: Baseline and Visit 8 (up to Month 48) ]
    Dual-energy X-ray absorptiometry (DEXA) scans for determination of BMD will be performed in participants aged 11-17 years, inclusive.

  7. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 2 (Month 12) [ Time Frame: Baseline and Visit 2 (Month 12) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 microgram [mcg]).

  8. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 4 (Month 24) [ Time Frame: Baseline and Visit 4 (Month 24) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).

  9. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 6 (Month 36) [ Time Frame: Baseline and Visit 6 (Month 36) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).

  10. Change From Baseline in Adrenocorticotropic Hormone (ACTH) Stimulation Level at Visit 8 (Month 48) [ Time Frame: Baseline and Visit 8 (up to Month 48) ]
    Adrenocorticotropic hormone stimulation testing will be performed by measuring the levels of cortisol in the blood following the injection of a synthetic form of ACTH (250 mcg).



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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245840


Contacts
Contact: Shire Contact 1 866-842-5335 ClinicalTransparency@shire.com

Locations
United States, Arizona
Del Sol Research Management Recruiting
Tucson, Arizona, United States, 85710
Contact: Elvia Parra    520-257-3881    Eparra@delsolresearch.com   
Principal Investigator: Gary Gottlieb         
United States, Arkansas
Arkansas Gastroenterology Recruiting
North Little Rock, Arkansas, United States, 72205
Contact: Robert Murphy       murphy@arkgi.net   
Principal Investigator: Robert Murphy         
United States, Colorado
Rocky Mountain Pediatric Gastroenterology Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Cassie Timm    303-790-1515    ctimm.rmpgi@gmail.com   
Principal Investigator: Theodore Stathos         
United States, Connecticut
Connecticut Clinical Research Foundation Recruiting
Bristol, Connecticut, United States, 06010
Contact: Cecile Guttermuth    860-585-3838    cgutterm@bristolhospital.org   
Principal Investigator: Salam Zakko         
Connecticut GI, PC - Research Division Recruiting
Farmington, Connecticut, United States, 06032
Contact: Rachel Tedesco    (860) 409-4567 xEXT108    rtedesco@connecticutgi.org   
Principal Investigator: David Chaletsky         
United States, Georgia
Gastroenterology Associates of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
Contact: Karen Shadwick    478-464-2600 ext 115    kshadwick@gaocg.com   
Principal Investigator: Shahriar Sedghi, MD         
United States, Indiana
Gastroenterology of Southern Indiana Recruiting
New Albany, Indiana, United States, 47150
Contact: Debra Walker    812-206-1702    dwalker@aquiant.com   
Principal Investigator: Steven Harrell         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ethan Hoover    319-384-9756    ethan-hoover@uiowa.edu   
Principal Investigator: Yehudith Assouline-Dayan, MD         
United States, Kansas
Cotton O'Neil Clinical Research Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Heather Hirst    785-368-0482    hhirst@stormontvail.org   
Principal Investigator: Curtis Baum         
United States, Louisiana
Gastroenterology Associates LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Dana Alexander    225-231-8783    danaa@dhcla.com   
Principal Investigator: Satyaprasad Alapati         
United States, New York
Long Island Gastrointestinal Research Group LLP Recruiting
Great Neck, New York, United States, 11023
Contact: Christine Raiser-Vignola    516-482-5976    christineraiser@ligiresearch.com   
Principal Investigator: MIchael Goldstein         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Catherine Bracken    919-843-7684    catherine_bracken@med.unc.edu   
Principal Investigator: Evan Dellon         
Clinical Research of Charlotte Recruiting
Charlotte, North Carolina, United States, 28277
Contact: Rebecca Schreiner    980-999-2055    rschreiner@crcharlotte.com   
Principal Investigator: Douglas Johnston         
United States, Ohio
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
Contact: Keith Friedenberg       kafried@roadrunner.com   
Principal Investigator: Keith Friedenberg         
United States, Texas
Houston Endoscopy and Research Center Recruiting
Houston, Texas, United States, 77079
Contact: Normie Stewart-Brown    713-932-6446    n.stewartbrown@workmail.com   
Principal Investigator: Vikram Jayanty         
United States, Utah
Advanced Research Institute Recruiting
Ogden, Utah, United States, 84405
Contact: Nephi Georgi    801-409-2040    nephi@advresearch.org   
Principal Investigator: John Lowe         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03245840     History of Changes
Other Study ID Numbers: SHP621-303
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists