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 EoE.
This study will consist of a 24-week Induction Phase followed by a 24-week Maintenance Phase.
The study is divided into 4 periods of time:
A 4-8 week Screening Period
A 24-week Induction Phase
A 24-week Maintenance Phase
And a 16-week Safety Follow-Up Period
Clinical laboratory tests, vital signs, physical examinations (including height and weight),pregnancy tests, esophagogastroduodenoscopy (EGD), clinical symptom assessments, subject reported outcomes, serum CC-93538 concentrations, serum antibodies to CC-93538 (to assess immunogenicity), concomitant medications, and AE assessments will be performed during the study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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