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An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE) (ORBIT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736409
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis (EoE) Drug: Oral Budesonide Suspension (OBS) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)
Actual Study Start Date : April 29, 2016
Estimated Primary Completion Date : November 22, 2019
Estimated Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Arms A OBS Completers/ Responders
Arm A Oral Budesonide Suspension Completers/ Responders
Drug: Oral Budesonide Suspension (OBS)
OBS 2mg twice daily

Placebo Comparator: Arm B OBS Completers/ Responders
Arm B Oral Budesonide Suspension Completers/ Responders. 1:1 randomization for Arms A and B
Drug: Placebo
Matching Placebo dose

Experimental: Arm C OBS Completers/ Non-Responders
Arm C Oral Budesonide Suspension Completers/ Non-Responders
Drug: Oral Budesonide Suspension (OBS)
OBS 2mg twice daily

Experimental: Arm D Placebo Completers
Arm D Placebo Completers
Drug: Oral Budesonide Suspension (OBS)
OBS 2mg twice daily




Primary Outcome Measures :
  1. Efficacy of SHP621 as measured by peak esophangeal eosinophil count [ Time Frame: 36 weeks ]
  2. Efficacy of SHP621 measured by the Dysphagia Symptom Questionnaire (DSQ) score [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. Participant long-term treatment response measured by peak eosinophil count from baseline to 36 weeks for subjects who were randomized to OBS treatment but did not respond after 16 weeks in SHP621-301 induction study [ Time Frame: 36 weeks ]
  2. Participant response to OBS treatment over 36 weeks as meaured by reduction in DSQ score for subjects who received placebo in the SHP621-301 induction study [ Time Frame: 36 weeks ]
  3. Participant response to reinitiating OBS treatment as measured by change in total endoscopy score for subjects who relapse after being randomized to placebo in the randomized withdrawal period [ Time Frame: 36 weeks ]
  4. Participant response as assessed by endoscopically identified esophageal features as measured by the EoE Endoscopic Reference Score (EREFS) [ Time Frame: 36 weeks ]
  5. Number of participants with adverse events by MedDRA preferred term as a measure of safety and tolerability [ Time Frame: 40 weeks ]
  6. Participant long-term treatment response measured by reduction in DSQ combined score from baseline to 36 weeks for subjects who were randomized to OBS treatment but did not respond after 16 weeks in SHP621-301 induction study [ Time Frame: 36 weeks ]
  7. Participant response to OBS treatment over 36 weeks as meaured by peak eosinophil count for subjects who received placebo in the SHP621-301 induction study [ Time Frame: 36 weeks ]
  8. Participant response to OBS treatment over 36 weeks as meaured by change in total endoscopy score for subjects who received placebo in the SHP621-301 induction study [ Time Frame: 36 weeks ]
  9. Participant response to reinitiating OBS treatment as measured by change in EREFS for subjects who relapse after being randomized to placebo in the randomized withdrawal period [ Time Frame: 36 weeks ]


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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:

  1. Subject completed SHP621-301 induction study.
  2. 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.
  3. Subject is male or female aged 11-55 years, inclusive, at time of consent for SHP621-301 study.
  4. Subject is willing and able to continue any dietary therapy, environmental therapy, and/or medical regimens (including gastric acid suppression; see exclusions below) in effect at the screening visit (Visit 0). There should be no changes to these regimens during study participation.
  5. All female subjects must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-hCG]) prior to enrollment into the study. Females of childbearing potential must agree to continue acceptable birth control measures (eg, abstinence, stable oral contraceptives, or double-barrier methods) throughout study participation and for 30 days following the last dose of investigational product.
  6. Subject is willing and has an understanding and ability to fully comply with study procedures including DSQ compliance (completed the DSQ on ≥70% of days in any 2 consecutive weeks of the screening period)and restrictions defined in this protocol

Exclusion Criteria:

  1. Subject has changes in medications that could affect the study or diet in the weeks since the final treatment evaluation visit (Visit 4) of the SHP621-301 study.
  2. Subject using immunomodulatory therapy since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated use of immunomodulatory therapy during the treatment period (except for any ongoing regimen of allergy shots); any temporary use (≤7 days) or initiation of new steroid treatment during the study should be documented and discussed with the medical monitor prospectively but cannot occur within 4 weeks of scheduled EGDs.
  3. Subject using swallowed topical corticosteroid for EoE or systemic corticosteroid for any condition since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated use during the treatment period; any temporary use (≤7 days) or initiation of new steroid treatment during the study should be documented and discussed with medical monitor prospectively but cannot occur within the 4 weeks of the scheduled EGDs.
  4. Subject on inhaled or intranasal steroids and not on a stable dose between the baseline visit (Visit 1) of the SHP621-301 study and the screening EGD of this study.
  5. Subject has initiated, discontinued, or changed dosage regimen of proton pump inhibitors (PPIs), H2 antagonists, antacids, antihistamines, or leukotriene inhibitors for any condition (such as gastroesophageal reflux disease, asthma or allergic rhinitis) since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated changes in the use of such medications during the treatment period.
  6. Subject using Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice) since the final treatment evaluation visit (Visit 4) of the SHP621-301 study or anticipated use of such medications during the treatment period.
  7. Subject has an appearance on screening EGD 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 >9mm).
  8. Subject is on a pure liquid diet or the six-food elimination diet.
  9. Subject has presence of esophageal varices at the EGD at the final treatment evaluation visit (Visit 4) of the SHP621-301 study.
  10. 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.
  11. Subject has other diseases causing or associated with esophageal eosinophilia, including hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or parasitic infection.
  12. 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 4) of the SHP621-301 study is not an exclusion as long as the subject received treatment for candidiasis and is expected to respond to treatment.

  13. Subject has acute or chronic infection or immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite infection, ocular herpes simplex, or chicken pox/measles.
  14. Subject has upper gastrointestinal bleeding identified in the EGD at the final treatment evaluation visit (Visit 4) of the SHP621-301 study or since the final treatment evaluation visit (Visit 4) of the SHP621-301 study.
  15. Subject has evidence of active infection with Helicobacter pylori.
  16. Subject has evidence of unstable asthma since the final treatment evaluation visit (Visit 4) of the SHP621-301 study.
  17. Subject is female and pregnant or nursing.
  18. 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.
  19. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.
  20. Subject is on sucralfate or anticipates using sucralfate during the treatment period.

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): NCT02736409


Locations
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United States, Alabama
Children's Hospital
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Del Sol Research Management
Tucson, Arizona, United States, 85710
Adobe Clinical Research LLC
Tucson, Arizona, United States, 85712
United States, Arkansas
Arkansas Gastroenterology
North Little Rock, Arkansas, United States, 72117
United States, California
GW Research, Inc.
Chula Vista, California, United States, 91910
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Colorado
Colorado Children's Hospital
Aurora, Colorado, United States, 80045
Asthma and Allergy Associates PC
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Pediatric Gastroenterology
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States, 06010
Connecticut GI, PC - Research Division
Farmington, Connecticut, United States, 06032
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Florida
Nature Coast Clinical Research LLC
Inverness, Florida, United States, 34452
Arnold Palmer Hospital For Children
Orlando, Florida, United States, 32806
United States, Georgia
Children's Center for Digestive Health Care
Atlanta, Georgia, United States, 30342
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
United States, Idaho
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic
Peoria, Illinois, United States, 61603
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Aquiant Research
New Albany, Indiana, United States, 47150
Gastroenterology of Southern Indiana
New Albany, Indiana, United States, 47150
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
United States, Louisiana
Gastroenterology Associates LLC
Baton Rouge, Louisiana, United States, 70809
Clinical Trials Management LLC
Metairie, Louisiana, United States, 70006
Louisiana Research Center LLC
Shreveport, Louisiana, United States, 71105
Clinical Trials of America LA LLC - PPDS
West Monroe, Louisiana, United States, 71291
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States, 48047
United States, Minnesota
Minnesota Gastroenterology PA
Plymouth, Minnesota, United States, 55446
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Montana
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59718
United States, New York
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States, 11023
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Asheville Gastroenterology Associates PA
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Clinical Research of Charlotte
Charlotte, North Carolina, United States, 28277
Clinical Trials of America-NC, LLC - PPDS
Mount Airy, North Carolina, United States, 27030
United States, Ohio
Consultants For Clinical Research Inc
Cincinnati, Ohio, United States, 45219
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Gastrointestinal and Liver Diseases Consultants PC
Dayton, Ohio, United States, 45415
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29615
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Houston Endoscopy and Research Center
Houston, Texas, United States, 77079
Digestive Health Center
Pasadena, Texas, United States, 77505
Texas Digestive Disease Consultants
Southlake, Texas, United States, 76092
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Advanced Research Institute
Sandy, Utah, United States, 84092
United States, Virginia
Emeritas Research Group
Lansdowne, Virginia, United States, 20176
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
Carilion Clinic
Roanoke, Virginia, United States, 24013
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02736409    
Other Study ID Numbers: SHP621-302
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.shiretrials.com website. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://www.shiretrials.com/en/our-commitment-to-transparency/data-sharing-with-researchers
Additional relevant MeSH terms:
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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