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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02736409
• Date of registration: 22/03/2016
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: 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
• Scientific 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)
• Date of first enrolment: April 29, 2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02736409
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Shire

Key inclusion & exclusion 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 [ß-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.



Age minimum: 11 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis (EoE)

Intervention(s)

Drug: Oral Budesonide Suspension (OBS)

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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 reduction in DSQ score for subjects who received placebo in the SHP621-301 induction study [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 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]

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]

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]

Secondary ID(s)

SHP621-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors