GSK 202018 contRAst-3

• Research type

  Research Study

• Full title

  A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.

• IRAS ID

  269887

• Contact name

  Peter Charles Taylor

• Contact email

  peter.taylor@kennedy.ox.ac.uk

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2019-000868-18

• Clinicaltrials.gov Identifier

  121958, IND

• Duration of Study in the UK

  2 years, 5 months, 18 days

• Research summary

  Summary of Research
  Rheumatoid arthritis (RA) is a chronic, systemic inflammatory autoimmune disease, associated with substantial disability and morbidity. RA affects approximately 0.5-1.0% of the worldwide population, primarily women, with a peak incidence of onset between 40 and 60 years of age. A substantial proportion of patients either fail to respond, or have inadequate response, to currently available RA therapies. Therefore, there is still a medical need for more effective treatments for RA with alternative mechanisms of action.

  This study involves research of a potential new drug, GSK3196165, also known as Otilimab, that is being developed for rheumatoid arthritis (RA) treatment. It will compare the activity of Otilimab in potential participants with moderately to severely active RA, in combination with conventional synthetic disease-modifying antirheumatic drug(s) (csDMARD), who have had an inadequate response to biologic DMARD(s) (bDMARD)(s) and/or JAK (Janus Kinase) inhibitors. The comparator drug (sarilumab) is approved in the United Kingdom for moderate-to-severe active rheumatoid arthritis.

  Depending on which treatment group participants are in, they will receive two doses of Otilimab (90 mg subcutaneous (SC) weekly or 150 mg SC weekly), which will be compared with placebo (to Week 12) and with sarilumab (200 mg SC every other week), all in combination with background csDMARD(s). Since the study is double blind the participants will not know whether they are receiving the study drug or comparator.

  The study consists of a screening phase of up to 6 weeks, a 24-week treatment phase and a safety follow-up visit at Week 34 (for any participant who does not transition into study 209564).

  Approximately 1050 - 1200 participants will be screened to achieve between 525 and 600 randomly assigned to study intervention.

  Summary of Results
  The plain language summary has been drafted and approved internally but not yet publicly available as we are waiting for the results summary to be released at CT.gov first.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  19/SC/0468

• Date of REC Opinion

  2 Dec 2019

• REC opinion

  Further Information Favourable Opinion