Extension Study of CEP-33457 for Systemic Lupus Erythematosus

• Research type

  Research Study

• Full title

  An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus

• IRAS ID

  59086

• Contact name

  Neil McHugh

• Sponsor organisation

  Cephalon, Inc.

• Eudract number

  2010-019293-32

• Research summary

  Systemic lupus erythematosus (SLE) is an autoimmune disease where the immune system (which normally protects the body from infections) mistakenly attacks itself. This causes inflammation in different parts of the body. Current treatments are based on immunosuppressive drugs (drugs that limit the immune system). Although these treatments can reduce death rate and lengthen life expectancy, they are aggressive and cause non-specific suppression of the immune system. This can result in numerous side effects that are sometimes worse than the disease itself. CEP-33457 is a protein with a new mechanism of action aimed at regulating the immune system. It is given as an injection under the skin. To date, approximately 120 patients have received CEP-33457 and it has been generally safe and well tolerated. A planned study to determine the effect of CEP-33457 compared to placebo (dummy drug) on patients with active SLE will enroll approximately 220 patients. Patients that complete that study may be eligible to participate in this extension study. The purpose of this study is to evaluate the long-term safety and tolerability of repeated doses of CEP-33457 every 4 weeks over 48 weeks. The study consists of a baseline visit, a 44-week treatment period and a final assessment 4 weeks after the last dose of CEP-33457. During the treatment period, patients will receive CEP-33457 every 4 weeks for a maximum of 12 doses. Overall, participation will last for up to 50 weeks and will include 13 visits to the hospital. Procedures to be undertaken during these visits include physical examinations, blood sampling, vital signs, ECGs, questionnaires and SLE assessments. This study is sponsored by Cephalon, Inc. At least 130 patients will participate in the United States and Europe, with 10-15 patients from 4 hospitals in the UK.

• REC name

  HSC REC A

• REC reference

  10/NIR01/50

• Date of REC Opinion

  27 Oct 2010

• REC opinion

  Further Information Favourable Opinion