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

Last updated: January 30, 2025
Sponsor: Shire
Overall Status: Terminated

Phase

3

Condition

Esophageal Disorders

Heartburn (Pediatric)

Heartburn

Treatment

Budesonide oral suspension

Clinical Study ID

NCT03245840
SHP621-303
  • Ages 11-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant completed the SHP621-302 (NCT02736409) extension study and is consideredby the investigator to potentially benefit from continued BOS investigationaltreatment.

  • Participant is able to provide written informed consent (participant, parent orlegal guardian and, as appropriate, participant assent) to participate in the studybefore completing any study-related procedures.

  • Females of childbearing potential must agree to continue acceptable birth controlmeasures (example (e.g.): abstinence, surgically sterile male partner, stable oralcontraceptives, or double-barrier methods) throughout study participation.

  • Participant is willing and has an understanding and ability to fully comply withstudy procedures and restrictions as defined in protocol.

Exclusion

Exclusion Criteria:

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

  • Participant anticipates using swallowed topical corticosteroid for EoE or systemiccorticosteroid for any condition during the treatment period; any temporary use (less than or equal to [≤] 7 days) or initiation of new steroid treatment during thestudy should be documented and discussed with the medical monitor prospectively butshould be avoided within 4 weeks of the scheduled esophagogastroduodenoscopy (EGDs).

  • Participant anticipates use of Cytochrome P450 3A4 inhibitors (e.g., ketoconazole,grapefruit juice) during the continuation study.

  • Participant has an appearance at the EGD at the final treatment evaluation visit ofSHP621-302 (NCT02736409) (Visit 8) of an esophageal stricture (high grade), asdefined by the presence of a lesion that does not allow passage of a diagnosticadult upper endoscope (e.g., with an insertion tube diameter of greater than (>) 9millimeter [mm]).

  • Participant has presence of esophageal varices at the EGD at the final treatmentevaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.

  • Participant has any current disease of the gastrointestinal tract, aside from EoE,including eosinophilic gastritis, enteritis, colitis, or proctitis, inflammatorybowel disease, or celiac disease.

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

  • Participant has oropharyngeal or esophageal candidiasis that failed to respond toprevious treatment. Diagnosis with oropharyngeal or esophageal candidiasis at orsince the final treatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409)study is not an exclusion as long as the participant is expected to respond totreatment.

  • Participant has a potentially serious acute or chronic infection or immunodeficiencycondition, including tuberculosis, fungal, bacterial, viral/parasite infection,ocular herpes simplex, or chicken pox/measles.

  • Participant has upper gastrointestinal bleeding identified at the EGD at the finaltreatment evaluation visit (Visit 8) of the SHP621-302 (NCT02736409) study.

  • Participant has evidence of active infection with Helicobacter pylori.

  • Participant has evidence of unstable asthma.

  • Participant is female and pregnant or nursing.

  • Participant has a history of intolerance, hypersensitivity, or idiosyncraticreaction to budesonide (or any other corticosteroids), or to any other ingredientsof the study medication.

  • Participant has a history or high risk of noncompliance with treatment or regularclinic visits.

Study Design

Total Participants: 133
Treatment Group(s): 1
Primary Treatment: Budesonide oral suspension
Phase: 3
Study Start date:
October 05, 2017
Estimated Completion Date:
April 26, 2022

Connect with a study center

  • Children's Hospital

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Del Sol Research Management

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Arkansas Gastroenterology

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Rady Children's Hospital San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Colorado Children's Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Asthma and Allergy Associates PC

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Rocky Mountain Pediatric Gastroenterology

    Denver, Colorado 80218
    United States

    Site Not Available

  • Rocky Mountain Pediatric Gastroenterology

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Connecticut GI, PC - Research Division

    Farmington, Connecticut 06032
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Connecticut GI

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Nature Coast Clinical Research LLC

    Inverness, Florida 34452
    United States

    Site Not Available

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Site Not Available

  • Childrens Center For Digestive Healthcare

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia 31201
    United States

    Site Not Available

  • Grand Teton Research Group

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Gastroenterology of Southern Indiana

    New Albany, Indiana 47150
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Indiana University

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Clinical Trials Management LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 00211
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Chestnut Hill, Massachusetts 02467
    United States

    Site Not Available

  • Minnesota Gastroenterology PA

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Mount Sinai Hospital, Icahn School of Medicine

    Astoria, New York 11102
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group LLP

    Great Neck, New York 11023
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Clinical Research of Charlotte

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Gastrointestinal and Liver Diseases Consultants PC

    Dayton, Ohio 45440
    United States

    Site Not Available

  • Great Lakes Gastroenterology

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Digestive Disease Specialists, Inc.

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Greenville Hospital

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Houston Endoscopy and Research Center

    Houston, Texas 77024
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Primary Children's Hospital, University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Emeritas Research Group

    Lansdowne Town Center, Virginia 20176
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.