Study of CEP-33457 for Systemic Lupus Erythematosus
Research type
Research Study
Full title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus
IRAS ID
58358
Contact name
Neil McHug
Sponsor organisation
Cephalon, Inc.
Eudract number
2010-018383-16
Clinicaltrials.gov Identifier
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. The purpose of this study is to determine the effect of CEP-33457 compared to placebo (dummy drug) on patients with active SLE. Patients aged 18-70 with active SLE and moderate disease activity may be able to participate. Eligible participants will be assigned by chance to receive either CEP-33457 or placebo. They will have a 50% chance of being assigned to either drug. The study consists of a screening period (up to 14 days), a 20-week treatment period and a 4-week follow-up period. Study drug will be given once every 4 weeks during the treatment period. Overall, participation will last for up to 26 weeks and will include 8 visits to the hospital. Procedures to be undertaken during these visits include physical examinations, blood sampling, vital signs, ECGs, questionnaires and SLE assessments. Participants that complete the study may be able to receive CEP-33457 in a subsequent open-label study. This study is sponsored by Cephalon, Inc. Approximately 220 patients will participate in the United States and Europe, with 12-20 patients from 4 hospitals in the UK.
REC name
HSC REC A
REC reference
10/NIR01/47
Date of REC Opinion
8 Sep 2010
REC opinion
Favourable Opinion