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)

NCT ID: NCT02736409

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2019-11-12

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.

Conditions

Eosinophilic Esophagitis (EoE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arms A OBS Completers/ Responders

Arm A Oral Budesonide Suspension Completers/ Responders

Group Type: EXPERIMENTAL

Oral Budesonide Suspension (OBS)

Intervention Type: DRUG

OBS 2mg twice daily

Arm B OBS Completers/ Responders

Arm B Oral Budesonide Suspension Completers/ Responders. 1:1 randomization for Arms A and B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo dose

Arm C OBS Completers/ Non-Responders

Arm C Oral Budesonide Suspension Completers/ Non-Responders

Group Type: EXPERIMENTAL

Oral Budesonide Suspension (OBS)

Intervention Type: DRUG

OBS 2mg twice daily

Arm D Placebo Completers

Arm D Placebo Completers

Group Type: EXPERIMENTAL

Oral Budesonide Suspension (OBS)

Intervention Type: DRUG

OBS 2mg twice daily

Interventions

Oral Budesonide Suspension (OBS)

OBS 2mg twice daily

Intervention Type: DRUG

Placebo

Matching Placebo dose

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Shire

Locations

Children's Hospital

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

Adobe Clinical Research LLC

Tucson, Arizona, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

GW Research, Inc.

Chula Vista, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

Colorado Children's Hospital

Aurora, Colorado, United States

Asthma and Allergy Associates PC

Colorado Springs, Colorado, United States

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, United States

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

Connecticut GI, PC - Research Division

Farmington, Connecticut, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nature Coast Clinical Research LLC

Inverness, Florida, United States

Arnold Palmer Hospital For Children

Orlando, Florida, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, United States

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic

Peoria, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Aquiant Research

New Albany, Indiana, United States

Gastroenterology of Southern Indiana

New Albany, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Gastroenterology Associates LLC

Baton Rouge, Louisiana, United States

Clinical Trials Management LLC

Metairie, Louisiana, United States

Louisiana Research Center LLC

Shreveport, Louisiana, United States

Clinical Trials of America LA LLC - PPDS

West Monroe, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

Minnesota Gastroenterology PA

Plymouth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Asheville Gastroenterology Associates PA

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Clinical Research of Charlotte

Charlotte, North Carolina, United States

Clinical Trials of America-NC, LLC - PPDS

Mount Airy, North Carolina, United States

Consultants For Clinical Research Inc

Cincinnati, Ohio, 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

Gastrointestinal and Liver Diseases Consultants PC

Dayton, Ohio, United States

Great Lakes Gastroenterology

Mentor, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Greenville Hospital System

Greenville, South Carolina, United States

Gastro One

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

San Antonio Military Medical Center

Fort Sam Houston, Texas, United States

Houston Endoscopy and Research Center

Houston, Texas, United States

Digestive Health Center

Pasadena, Texas, United States

Texas Digestive Disease Consultants

Southlake, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Advanced Research Institute

Sandy City, Utah, United States

Emeritas Research Group

Lansdowne Town Center, Virginia, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

Countries

United States

References

Dellon ES, Collins MH, Katzka DA, Mukkada VA, Falk GW, Zhang W, Goodwin B, Terreri B, Boules M, Desai NK, Hirano I. Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis. Therap Adv Gastroenterol. 2024 Dec 23;17:17562848241307602. doi: 10.1177/17562848241307602. eCollection 2024.

Reference Type: DERIVED

PMID: 39735351 (View on PubMed)

Dellon ES, Collins MH, Katzka DA, Mukkada VA, Falk GW, Morey R, Goodwin B, Eisner JD, Lan L, Desai NK, Williams J, Hirano I; ORBIT2/SHP621-302 Investigators. Long-Term Treatment of Eosinophilic Esophagitis With Budesonide Oral Suspension. Clin Gastroenterol Hepatol. 2022 Jul;20(7):1488-1498.e11. doi: 10.1016/j.cgh.2021.06.020. Epub 2021 Jun 26.

Reference Type: DERIVED

PMID: 34182150 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SHP621-302

Identifier Type: -

Identifier Source: org_study_id