Validating novel therapeutic targets in Autoimmune diseases, Version 1
Research type
Research Study
Full title
Validating novel therapeutic targets in Systemic lupus erythematosus (SLE) and associated Autoimmune Inflammatory Disorders
IRAS ID
231683
Contact name
Debasish Pyne
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Systemic lupus erythematosus (SLE) is a heterogeneous group of multiple-system autoimmune diseases that affects approximately 1 in 700 to 5000 individuals. Many patients with severe disease are refractory to conventional treatments. In the past 50 years, only one biological treatment, Belimumab – a monoclonal antibody against B-cell activating factor (BAFF), had been successfully developed for SLE and unmet medical needs remain high in this area. SLE also has commonly associated conditions such as Anti-phospholipid syndrome, Sjogrens Syndrome and myositis where therapeutic options for refractory diseases are limited. There are currently a number of novel therapeutic targets under clinical development in SLE. Notably, the blockade of CD40L demonstrated promising efficacy and safety profile in clinical trials, providing an opportunity to advance the management of moderate to severe SLE.
This translational research study proposal, a collaboration between Barts Health NHS Trust and UCB Celltech, aims to further understand the pathophysiology of SLE in relation to CD40L biology and other immunological pathways to support the development of an exciting new therapy targeting CD40L. Moreover, this study will explore if the knowledge gained in SLE through work on CD40L or related cellular and humoral immunological pathways could be translatable to other autoimmune inflammatory conditions often associated with SLE such as myositis, Sjogren’s syndrome and anti-phospholipid syndrome.
We aim to recruit 70 SLE patients and 35 other patients with autoimmune inflammatory disorders from the Barts Lupus Unit, Barts Health NHS Trust over a period of 18 months. Patients will be asked to donate blood samples for scientific research where work will be carried out at UCB Celltech. This is not a clinical trial and there will be no diagnostic or medicinal interventions for patients. Both Barts Health and UCB are committed to improving the lives of people with lupus and this project will be a crucial integral part of an ongoing drug development program which will hopefully bring a new effective treatment for patients with moderate to severe disease, preventing long term organ damage and premature mortality.REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0380
Date of REC Opinion
14 Sep 2017
REC opinion
Further Information Favourable Opinion