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)

NCT02736409 | Completed Phase 3 Results

• 1 other identifier: SHP621-302
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 62

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)

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Had Relapse During the Entire Week 36 Period

  Relapse (Yes/No) was defined as meeting both the eosinophil histology relapse criterion and the dysphagia symptom relapse criterion. Eosinophil histology relapse was defined as an eosinophil count of greater than or equal to(\> or =) 15 per high-power field (eos/hpf) from at least 2 of 3 levels of the esophagus. Dysphagia symptom relapse was defined as having at least 4 days of dysphagia (with answer 'Yes' for question 2 in DSQ \[Dysphagia Symptom Questionnaire\]) in the 2-week period prior to the scheduled visit, as determined by the DSQ.

  Week 36

Secondary Outcomes (34)

• Proportion of Participants With Long-term Treatment Response From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 36 of Current Study

  Week 36

• Proportion of Participants With Long-term Treatment Response From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 36

  Week 36

• Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Less Than or Equal to (<or=6)/High-Powered Field [HPF]) at Week 12 and Week 36

  Week 12 and Week 36

• Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Induction Study (SHP621-301 [NCT02605837]) Baseline at Week 12 and Week 36

  Baseline of SHP621-301 (NCT02605837), Week 12 and Week 36

• Proportion of Participants Who Had at Least a 30 Percent (%) Change in DSQ Combined Score From Current Study (SHP621-302 [NCT02736409]) Baseline at Week 12 and Week 36

  Baseline of Current Study (SHP621-302 [NCT02736409]), Week 12 and Week 36

Other Outcomes (1)

• Proportion of Participants Who Had a Histologic Response (Eosinophil Count of Greater Than or Equal to (>or=15)/High-Powered Field [HPF]) Before or at Week 12 and Before or at Week 36

  Week 12 and Week 36

Study Arms (4)

Arms A OBS Completers/ Responders

EXPERIMENTAL

Arm A Oral Budesonide Suspension Completers/ Responders

Drug: Oral Budesonide Suspension (OBS)

Arm B OBS Completers/ Responders

PLACEBO COMPARATOR

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

Drug: Placebo

Arm C OBS Completers/ Non-Responders

EXPERIMENTAL

Arm C Oral Budesonide Suspension Completers/ Non-Responders

Drug: Oral Budesonide Suspension (OBS)

Arm D Placebo Completers

EXPERIMENTAL

Arm D Placebo Completers

Drug: Oral Budesonide Suspension (OBS)

Interventions

Oral Budesonide Suspension (OBS) DRUG

OBS 2mg twice daily

Arm C OBS Completers/ Non-Responders; Arm D Placebo Completers; Arms A OBS Completers/ Responders

Placebo DRUG

Matching Placebo dose

Arm B OBS Completers/ Responders

Eligibility Criteria

• Age: 11 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject completed SHP621-301 induction study.
• 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.
• Subject is male or female aged 11-55 years, inclusive, at time of consent for SHP621-301 study.
• 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.
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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).
• Subject is on a pure liquid diet or the six-food elimination diet.
• Subject has presence of esophageal varices at the EGD at the final treatment evaluation visit (Visit 4) of the SHP621-301 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.
• Subject has 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 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.
• Subject has evidence of active infection with Helicobacter pylori.

Sponsors & Collaborators

• Shire: lead

Study Sites (62)

Children's Hospital

Birmingham, Alabama, 35233, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Del Sol Research Management

Tucson, Arizona, 85710, United States

Location

Adobe Clinical Research LLC

Tucson, Arizona, 85712, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

GW Research, Inc.

Chula Vista, California, 91910, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Colorado Children's Hospital

Aurora, Colorado, 80045, United States

Location

Asthma and Allergy Associates PC

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Pediatric Gastroenterology

Lone Tree, Colorado, 80124, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

Connecticut GI, PC - Research Division

Farmington, Connecticut, 06032, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Nature Coast Clinical Research LLC

Inverness, Florida, 34452, United States

Location

Arnold Palmer Hospital For Children

Orlando, Florida, 32806, United States

Location

Children's Center for Digestive Health Care

Atlanta, Georgia, 30342, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201, United States

Location

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois College of Medicine at Peoria Pediatric Subspecialty Clinic

Peoria, Illinois, 61603, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Aquiant Research

New Albany, Indiana, 47150, United States

Location

Gastroenterology of Southern Indiana

New Albany, Indiana, 47150, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809, United States

Location

Clinical Trials Management LLC

Metairie, Louisiana, 70006, United States

Location

Louisiana Research Center LLC

Shreveport, Louisiana, 71105, United States

Location

Clinical Trials of America LA LLC - PPDS

West Monroe, Louisiana, 71291, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Minnesota Gastroenterology PA

Plymouth, Minnesota, 55446, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59718, United States

Location

Long Island Gastrointestinal Research Group LLP

Great Neck, New York, 11023, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Asheville Gastroenterology Associates PA

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Clinical Research of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Clinical Trials of America-NC, LLC - PPDS

Mount Airy, North Carolina, 27030, United States

Location

Consultants For Clinical Research Inc

Cincinnati, Ohio, 45219, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Gastrointestinal and Liver Diseases Consultants PC

Dayton, Ohio, 45415, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29615, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Houston Endoscopy and Research Center

Houston, Texas, 77079, United States

Location

Digestive Health Center

Pasadena, Texas, 77505, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Advanced Research Institute

Sandy City, Utah, 84092, United States

Location

Emeritas Research Group

Lansdowne Town Center, Virginia, 20176, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

Related Publications (2)

• 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.

  PMID: 39735351 DERIVED

• 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.

  PMID: 34182150 DERIVED

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Shire

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: February 19, 2025
• Results First Posted: January 13, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (62)