Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) with Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study
Clinical Trial Information
Trial Contact: Parrimon, Yozandra; Tilme, Linda
IRB No: 16.020.02
Protocol Abbrev: Shire SHP621-301
Principal Investigator: Yamen Smadi, MD
Sub Investigators: Horvath, Karoly MD; Mehta, Devendra MD; Safder, Shaista MD; Raijer, Carolina, ARNP; Jackson, Teri ARNP; Bornstein, Jeffrey MD
Phase: Drug: Phase III
Age Group: Pediatric
Treatment: OBS (Oral Budesonide Suspension)
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT02605837
To demonstrate in a placebo-controlled trial that:
· OBS induces a histologic response (eosinophilic count ≤6/high-powered field [HPF]) in adolescent and adult subjects with eosinophilic esophagitis (EoE) over a 12-week course of therapy.
· OBS reduces dysphagia, as measured by the Dysphagia Symptom Questionnaire (DSQ), by at least 30% from baseline in adolescent and adult subjects with EoE over a 12-week course of therapy.
1) Subject has histologic evidence of EoE with a peak eosinophil count of ≥15/HPF, from 2 of 3 (proximal, mid-, and/or distal) levels of the esophagus at the screening endoscopy.
2) Subject has a history of clinical symptoms of esophageal dysfunction (e.g., eating problems, abdominal pain, heartburn, dysphagia, vomiting, food impaction, weight loss) intermittently or continuously at screening (Visit -1).
3) Subject must have experienced dysphagia on a minimum of 4 days in any 2 consecutive weeks of the screening period and in the last 2 weeks prior to the baseline visit (Visit 1).
4) Subject must not have PPI-responsive EoE based on esophageal biopsies performed after the patient has been on at least 8 weeks of high-dose PPI therapy.