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.
The participants are required to sign the consent form. If you decide to participate, you will be required to attend study visits, follow doctor's instructions and take the study drug as instructed. You will be required to complete electronic questionnsires, and tell you doctor about any health problems, symptoms and drugs that you are taking. There are two visits during screening, including EGD procedure with biopsies. All the procedures during screening are done to determine if you are qualified to participate in the study. If the screening tests show that you can take part in this study, a computer program will make the assignment of which study drug you are to receive. You will be assigned to start the study by receiving either active drug (360 mg of CC-93538), or placebo. Both active drug and placebo will be given weekly by subcutaneous injection. You will be asked to have blood test done for serum and for biomarkers at most of your visits (except week 20). Physical exam and pregnancy's tests will be done at screening visit, and every visit during the induction after week 4. the ECG test will be done at screening. Similarly, the blood work and pregnancy's tests will be done at every visit during the maintenance. urinalysis and physical exam will also be done at some visits in the maintenance. Your vital signs will be monitored throughout the study.
$750 induction, $565 Maintenance max
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
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