RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED INDUCTION for Adolescent and Adults
A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis
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Clinical Trial Information
Trial Contact: Tilme, Linda; Beltran, Yajira; Perez, Ivana
Trial Phone: 321.843.5278 ; 321.841.7619 ; 321-841-9772
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IRB No: 20.210.12
Protocol Abbrev: Celgene CC-93538-EE-001
Principal Investigator: Yamen Smadi, MD
Phase: Drug: Phase III
Age Group: Adult;Pediatric
Secondary Protocol No: CC-93538-EE-001
Treatment: Drug: CC-93538 or placebo
Therapies Involved: Medication
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Objective
To assess the efficacy of CC-93538 versus placebo in reducing dysphagia symptoms
at 24 weeks
To assess the efficacy of CC-93538 versus placebo in reducing esophageal eosinophil
counts at 24 weeks -
Key Eligibility
Subject has histologic evidence of EoE, defined as a peak count of ≥ 15 eosinophils per
high-power field (hpf) at any 2 levels of the esophagus (proximal, mid, and/or distal)
when off anti-inflammatory therapy (eg, corticosteroids, see Exclusion Criterion 7) for
EoE.
