Efficacy & Safety of CC-93538 in Adult & Adolescent Subjects with Eosinophilic Esophagitis

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1003545

• Contact name

  GSM-CT Representative

• Sponsor organisation

  Celgene International II Sàrl

• Eudract number

  2020-004336-16

• 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 study is to see if CC-93538 is safe & effective as a possible treatment for EoE & to help confirm earlier results from a previous study which suggests this may be the case. A comparison will be made between patients who receive CC-93538 & patients who receive a placebo (looks like CC-93538 with no active ingredient). The study is divided into 4 periods of time; 4-8 week Screening Period, 24-week Induction Phase, 24-week Maintenance Phase & 16-week Safety Follow-Up Period. There will be different study procedures & tests that performed during the study. The maximum time a patient will be in the study is approximately 72 weeks & study drug is taken once a week. Weekly treatment consists of 2 subcutaneous injections, given sequentially.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0167

• Date of REC Opinion

  22 Apr 2021

• REC opinion

  Further Information Favourable Opinion