OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension
Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension
1 other identifier
interventional
93
1 country
23
Brief Summary
This is a clinical trial to test an experimental drug for the treatment of Eosinophilic Esophagitis (EoE)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
July 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2014
CompletedResults Posted
Study results publicly available
December 7, 2015
CompletedJune 8, 2021
May 1, 2021
2.3 years
July 13, 2012
September 30, 2015
May 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent of Participants Who Were Histologic Responders
Histologic response was defined as a peak eosinophil count \</= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.
Week 16
Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation
Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 \[14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data\]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.
Baseline, Week 16
Secondary Outcomes (19)
Change From Baseline in The DSQ Score Over Time
Baseline, Weeks 8 and 12
Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation
Baseline, Week 16
Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation
Week 16
Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation
Baseline, Week 16
Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation
Week 16
- +14 more secondary outcomes
Study Arms (2)
Oral Budesonide Suspension
EXPERIMENTALTaken once or twice daily for up to 40 weeks
Matching Placebo
PLACEBO COMPARATORTaken once or twice daily for 20 weeks
Interventions
OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period
Eligibility Criteria
You may qualify if:
- Males and Females, age 11-40
- Histologic evidence of EoE
- History of clinical symptoms of EoE including dysphagia
- Willing to continue with dietary, environmental or medical therapy
- Ability to read and understand english
- Written Consent
You may not qualify if:
- Any Medical condition that may compromise the safety of the subjects or interfere with the signs and symptoms of EoE
- Use of immunomodulatory therapy
- Current use of swallowed corticosteroids
- Esophageal strictures,varices or upper GI bleed
- Other current diseases of the GI tract
- Current viral infection or immunodeficiency condition
- Pregnancy
- Hypersensitivity to budesonide
- History of non compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (23)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
UCSD Rady Children's Hospital
San Diego, California, 92123, United States
The Children's Hospital
Aurora, Colorado, 80045, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, 30342, United States
Northwestern Scool of Medicine
Chicago, Illinois, 60611, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Center for Children's Digestive Health
Park Ridge, Illinois, 60068, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
The Mayo Clinic
Rochester, Minnesota, 55905, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
The Cincinnati Center for Eosinophilic Disorders
Cincinnati, Ohio, 45229, United States
Great Lakes Gastroenterology
Mentor, Ohio, 44060, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Children's Center for Digestive Health
Greenville, South Carolina, 29615, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Utah Healthcare
Salt Lake City, Utah, 84132, United States
Carilion Pediatric Gastroenterology
Roanoke, Virginia, 24013, United States
Related Publications (5)
Mukkada VA, Gupta SK, Gold BD, Dellon ES, Collins MH, Katzka DA, Falk GW, Williams J, Zhang W, Boules M, Hirano I, Desai NK. Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis. J Pediatr Gastroenterol Nutr. 2023 Dec 1;77(6):760-768. doi: 10.1097/MPG.0000000000003948. Epub 2023 Sep 18.
PMID: 37718471DERIVEDDellon ES, Collins MH, Katzka DA, Hudgens S, Lan L, Williams J, Vera-Llonch M, Hirano I. Improvements in Dysphagia and Pain With Swallowing in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension. Clin Gastroenterol Hepatol. 2021 Apr;19(4):699-706.e4. doi: 10.1016/j.cgh.2020.03.060. Epub 2020 Apr 6.
PMID: 32272243DERIVEDHirano I, Dellon ES, Collins MH, Williams J, Lan L, Katzka DA. Clinical Features at Baseline Cannot Predict Symptom Response to Placebo in Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2126-2128.e1. doi: 10.1016/j.cgh.2018.11.045. Epub 2018 Nov 28.
PMID: 30502508DERIVEDDellon ES, Katzka DA, Collins MH, Gupta SK, Lan L, Williams J, Hirano I. Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Mar;17(4):666-673.e8. doi: 10.1016/j.cgh.2018.05.051. Epub 2018 Jun 12.
PMID: 29902649DERIVEDDellon ES, Katzka DA, Collins MH, Hamdani M, Gupta SK, Hirano I; MP-101-06 Investigators. Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis. Gastroenterology. 2017 Mar;152(4):776-786.e5. doi: 10.1053/j.gastro.2016.11.021. Epub 2016 Nov 23.
PMID: 27889574DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2012
First Posted
July 17, 2012
Study Start
July 23, 2012
Primary Completion
October 30, 2014
Study Completion
October 30, 2014
Last Updated
June 8, 2021
Results First Posted
December 7, 2015
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. 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.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.