GA30066-Open label GDC-0853 in patients with moderate to severe SLE
Research type
Research Study
Full title
A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
IRAS ID
234825
Contact name
Kevin Davies
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2017-001764-37
Clinicaltrials.gov Identifier
130011, IND
Duration of Study in the UK
2 years, 3 months, 28 days
Research summary
Systemic Lupus Erythematosus (SLE) is a chronic immune complex-mediated inflammatory disease that is due to immune system attack of tissues and organs. Inflammation caused by SLE can affect any organ system — including joints, skin, kidneys and blood cells. Typically, SLE follows a relapsing-remitting course with intermittent periods of disease activity (flare) interspersed with periods of relative quiescence (inactivity). The prevalence of SLE ranges between 65 and 155 per 100,000 people and varies with sex, race and ethnicity. Currently there are limited medications for the treatment of SLE, this is therefore an area of unmet medical need.
This study is an open-label extension study of a medication called GDC 0853. To take part in this study participants must have completed the treatment period for Study GA30044 and have moderate to severe SLE. The study’s purpose is to evaluate the effects, good or bad, of GDC-0853 on SLE, all participants will receive GDC 0853. GDC-0853 blocks a protein called Bruton’s tyrosine kinase, which is involved in the function of immune cells.
The treatment period in this study will last up to 48 weeks, with a follow-up visit 8 weeks after the last dose of GDC-0853. During the treatment period participants will take up to four pills twice a day and attend the clinic every month. Up to 240 patients will take part in this study.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1858
Date of REC Opinion
14 Nov 2017
REC opinion
Favourable Opinion