Safety, blood levels and effects of repeated doses of AMG 557; v1
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, ascending, multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 557 in subjects with Systemic Lupus Erythematosus.
IRAS ID
16501
Contact name
Malcolm Boyce
Sponsor organisation
Amgen, Inc
Eudract number
2008-005302-39
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
AMG 557 is an experimental treatment for systemic lupus erythematosus (SLE) - an illness in which the body attacks its own organs, such as the skin, joints and kidneys. SLE affects the immune system - the white blood cells and antibodies that defend the body against infections. A particular protein on white blood cells is overactive in SLE patients. We hope that AMG 557, which is a monoclonal antibody, will block that overactive protein. We'll use keyhole limpet haemocyanin (KLH) - a protein from shellfish - to test how AMG 557 affects the immune system. We'll test repeated doses of AMG 557, to find out its side effects, blood levels and effects on the immune system. We'll also take blood samples to study factors that may help to identify the patients likely to benefit most from AMG 557 or other medicines, or that may help to monitor SLE. We'll also study genes that are linked to SLE or that control how the body handles and responds to AMG 557. 32 patients with SLE, aged 18-70, will receive 7 injections of study medicine over a 12-week period. We'll start with a small dose of AMG 557, and increase it as the study progresses. Some participants will take dummy medicine instead of AMG 557 - neither they nor we will know which one they??re taking. Participants will also have 2 injections of KLH. Participants will attend 21 outpatient visits over 40 weeks. This is the first study of repeated doses of AMG 557, so we don??t know if participants will benefit from the study medicine, but they might benefit from our tests. A pharmaceutical company, Amgen, is funding the study. The study will take place at 1 centre in London, and at centres in North America. Patients will be recruited from SLE clinics by rheumatologists.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
09/H0707/65
Date of REC Opinion
16 Nov 2009
REC opinion
Further Information Favourable Opinion