Oral Budesonide Suspension in Eosinophilic Esophagitis

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)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Anthony, Susan; Beltran, Yajira; Tilme, Linda

  • IRB No: 16.068.06

    Protocol Abbrev: Shire SHP621-302

    Principal Investigator: Yamen Smadi, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: SHP621-302

    Treatment: Oral Budesonide Suspension

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT02736409

  • Objective

    1) To evaluate the maintenance of efficacy over 36 weeks, as measured by the peak eosinophilic count and the Dysphagia Symptom Questionnaire (DSQ) score, through a randomized withdrawal design for subjects who responded to 12 weeks of OBS treatment (2 mg twice daily) with a peak count of ≤6 eosinophils (eos)/high-powered field (HPF) across all available esophageal levels at the final treatment visit and a ≥30% reduction in DSQ score from baseline during the SHP621-301
    induction study
    2) To evaluate the long-term treatment response over an extended period of 36 weeks for subjects who were randomized to OBS treatment but did not respond after 12 weeks in the SHP621-301 induction study (subject did not have a peak count of ≤6 eos/HPF across all available esophageal
    levels at the final treatment visit and/or a ≥30% reduction in DSQ score from baseline)

  • Key Eligibility

    Subject completed SHP621-301 induction study and wishes to continue.