Long-term safety of CC-93538 in Adults & Adolescents with Eosinophilic Esophagitis
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS
IRAS ID
1004065
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene International II SARL
Eudract number
2020-004335-24
Research summary
Eosinophilic Esophagitis (EoE) is a chronic, allergic, inflammatory disorder of the oesophagus. The allergen is often not known, is usually something in the diet or something that has been inhaled & causes chronic, or repeating episodes of inflammation in the oesophagus. Inflammation can result in difficulty swallowing (dysphagia). Other symptoms may include a feeling that food is stuck between the throat & stomach, chest pain or upper abdominal pain. Also, a lab test will show a type of white blood cell (eosinophil) to be present in large numbers which is not normal. CC-93538 (aka cendakimab), the study drug, is a biologic agent made in a lab & designed to stop the body’s immune system reacting to the allergen for e.g. by attracting too many white blood cells (especially eosinophils) to the oesophagus. CC-93538 blocks a natural substance in the body called interleukin-13 (IL-13). The immune system makes IL-13 which sends many eosinophils to assist in responding to the allergen in the oesophagus. If CC-93538 can block enough IL-13, then the eosinophils will not be called to help & inflammation might be lessened or stopped. The purpose of this open-label extension (OLE) study is to evaluate the long-term safety and tolerability of CC-93538 in subjects with EoE. The study will consist only of eligible patients from the core study (CC-93538-EE-001), and all will receive CC-93538 weekly, given by 2 subcutaneous injections. The study consists of an open-label treatment period which ends with an end of treatment visit followed by 2 safety follow up visits. Participants are anticipated to be on the study for a minimum of 2 years. This may be extended if they are benefitting from treatment. The procedures in this OLE study are similar to those in the core study and there should be no difference in how any procedure will be performed.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0610
Date of REC Opinion
9 Nov 2021
REC opinion
Further Information Favourable Opinion