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

Brief description of study

The purpose of this study is to see if CC-93538 is safe and effective as a possible treatment for EoE. To do this, a comparison will be made between subjects who receive CC-93538 and subjects who receive a placebo (a ‘dummy treatment’ that looks like CC-93538 but contains no active ingredient). The purpose of this Phase 3 study is to help confirm the earlier results from a completed Phase 2 study, which suggests that CC-93538 may be safe and effective in treating patients with Eosinophilic Esophagitis (EoE). EoE is a chronic, allergic, inflammatory disorder of the esophagus. The allergic substance, which is called an ‘allergen’, is often not known, and there may be more than one allergen causing your condition. CC-93538 (also known as cendakimab) is a biologic agent, called a monoclonal antibody, which is made in a laboratory and designed to stop the body’s own immune (defense) system from reacting to the allergen, for example by attracting too many white blood cells (especially eosinophils) to the esophagus. CC-93538 does this by blocking a natural substance in the body called interleukin-13 (IL-13).


Clinical Study Identifier: s21-00457
ClinicalTrials.gov Identifier: NCT04753697
Principal Investigator: Rita M. Knotts.
Other Investigator: Abraham R Khan.


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