GA30044 - GDC-0853 v placebo in patients with moderate to severe SLE

• Research type

  Research Study

• Full title

  A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

• IRAS ID

  214264

• Contact name

  Kevin Davies

• Contact email

  k.a.davies@bsms.ac.uk

• Sponsor organisation

  Genentech, Inc.

• Eudract number

  2016-001039-11

• Duration of Study in the UK

  2 years, 10 months, 0 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,. The prevalence of SLE ranges between 65 and 155 per 100,000 people and varies with sex, race and ethnicity.

  The purpose of this study is to compare the effects, good or bad, of a new investigational drug GDC-0853 for SLE verses placebo (an inactive substance that looks like GDC-0853). Some participants will receive GDC-0853 and others will receive placebo. In addition to GDC-0853 or placebo, participants will continue to take their regular SLE medication during the study.

  Participants will be randomly assigned to 1 of 3 treatment groups. Neither participants nor their study doctor may choose or know the group assigned. Participants will have a one in three chance of being placed in any group.

  No matter which group they are in, participants will take 4 pills twice a day (four in the morning and four in the evening), as follows:
  • Group A: Treatment with active GDC-0853 at a dose of 200 mg twice a day
  • Group B: Treatment with active GDC-0853 at a dose of 150 mg once a day and treatment with placebo pills once a day
  • Group C: Treatment with placebo pills twice a day

  If a patient experiences increased clinical activity of their SLE trial defined burst (high dose over short period of time) and rescue therapies are available. The maximum length of time on the study for a participant is 60 weeks, including screening for up to 28 days, treatment for 48 weeks, and a safety follow-up period for 8 weeks or possibly enrolment into an Open Label Extension study. Approximately 240 participants worldwide will take part in this study.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  16/LO/1811

• Date of REC Opinion

  16 Nov 2016

• REC opinion

  Further Information Favourable Opinion