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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (OBS) Drug: Placebo | Phase 3 |
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 |

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 |
- Efficacy of SHP621 as measured by peak esophangeal eosinophil count [ Time Frame: 36 weeks ]
- Efficacy of SHP621 measured by the Dysphagia Symptom Questionnaire (DSQ) score [ Time Frame: 36 weeks ]
- 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 ]
- 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 ]
- 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 ]
- Participant response as assessed by endoscopically identified esophageal features as measured by the EoE Endoscopic Reference Score (EREFS) [ Time Frame: 36 weeks ]
- Number of participants with adverse events by MedDRA preferred term as a measure of safety and tolerability [ Time Frame: 40 weeks ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 11 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
- 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
Exclusion Criteria:
- 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.
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.
- 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.
- Subject has evidence of unstable asthma since the final treatment evaluation visit (Visit 4) of the SHP621-301 study.
- Subject is female and pregnant or nursing.
- 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.
- Subject has a history or high risk of noncompliance with treatment or regular clinic visits.
- Subject is on sucralfate or anticipates using sucralfate during the treatment period.

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

Study Director: | Study Director | Shire |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT02736409 History of Changes |
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 |
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 |