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CC-93538-EE-001 – A PHASE 3, MULTI-CENTER, MULTI-NATIONAL, 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

The scope of the study is to use a novel biologic drug, CC-93538, against symptoms of esophageal dysfunction and inflammation in subjects with Eosinophilic esophagitis (EoE). The CC-93538 will target the IL-13 receptor, a key driver of disease pathology in EoE. The phase 3 program will evaluate the safety and efficacy of CC-93538 in placebo-controlled Induction, Maintenance, and Open-Label Extension study.
Zvjezdana "Stella" Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-0003, ext=322136
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04753697
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Inclusion Criteria:
Adults with body weight more than 40 kg
Histologic evidence of EoE
Symptoms of dysphagia
Previous therapy with PPI medications, intolerant or inadequate corticosteroid response, or steroid responders/naive
Must agree to maintain stable diet
Exclusion Criteria:
Active, ongoing infections
Liver function impairment, structural abnormality of esophagus
Receiving concurrent treatment with another IP, or the same drug previously
Currently is succesfully treated for EoE with dietary modifications
Currently receiving corticosteroids
Digestive Systems & Liver Disease
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Study Locations

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Location
Hershey, PA