PK, safety, tolerability and PD of sc epratuzumab
Research type
Research Study
Full title
AN OPEN-LABEL, PARALLEL-GROUP, SINGLE DOSE ESCALATION STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF SUBCUTANEOUS EPRATUZUMAB IN HEALTHY CAUCASIAN AND JAPANESE SUBJECTS
IRAS ID
164595
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2014-000911-15
Clinicaltrials.gov Identifier
Research summary
We are conducting a clinical trial with a new medication known as epratuzumab which is being developed for the treatment of systemic lupus erythematosus (SLE). SLE is an autoimmune disease which is incurable but it can be treated. The underlying cause of autoimmune diseases is not fully known but symptoms range from fatigue, skin rash, joint pain and swelling to life threatening such as cardiovascular inflammation as it can occur in any part of the body. Currently, corticosteroids drugs are the main treatments used to control autoimmune diseases, including SLE. However, these drugs may have several undesirable severe side effects, hence there is an unmet need for additional treatments for SLE.\n\nTo date, UCB has conducted 13 clinical studies to assess the safety and efficacy of epratuzumab in SLE patients (mostly) and some Sjogren’s Syndrome (pSS) patients by using an intravenous (iv) formulation. A subcutaneous (sc) injectable formulation has recently been developed to provide a more convenient administration of epratuzumab. Hence this study will compare the blood levels, safety and tolerability of the sc formulation in healthy Caucasian and Japanese volunteers. The effect of epratuzumab on B cells; which are a type of immune cells will be also be assessed (i.e. pharmacodynamics) as these cells are thought to play an important role in SLE. The presence and levels of potential antibodies to epratuzumab that may be produced in the blood will also be measured. The results from this study will help us to determine the appropriate sc dose regimens that can be used in future trials and will be expected to have clinical benefit in SLE patients.\n\nThe study will also compare the data for Caucasian and Japanese volunteers when given by iv infusion or sc injection, to provide data to allow the use of epratuzumab in Japanese populations.\n\n\n
REC name
HSC REC B
REC reference
14/NI/1103
Date of REC Opinion
3 Nov 2014
REC opinion
Further Information Favourable Opinion