* Phase 3 Study to Evaluate BIIB059 in Active SLE

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care

• IRAS ID

  303394

• Contact name

  David D'Cruz

• Contact email

  david.d'cruz@KCL.ac.uk

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2020-005776-35

• Clinicaltrials.gov Identifier

  IND NUMBER, 117288

• Duration of Study in the UK

  3 years, 10 months, 12 days

• Research summary

  This study will look at an investigational drug called BIIB059 which is evaluated in order to better understand if it is effective or safe in Adult Participants With Active Systemic Lupus Erythematosus when also receiving background nonbiologic Lupus Standard of Care. This phase 3 study will include patients aged 18 and older receiving background nonbiologic lupus standard of care therapy. Participants will be randomized to receive BIIB059 450 mg, BIIB059 225 mg, or placebo (looks like the study drug but it doesn’t contain any active ingredient) subcutaneously (under the skin) Q4W every 4 weeks randomised means the participant will be assigned by chance, like the flip of a coin, to 1 of 3 treatment groups. Double blind means that neither the participant nor the study doctor/study staff will know which treatment group the participant have been assigned to.
  For all participants enrolled, the study will consist of 3 periods:
  - a Screening Period of up to 4 weeks;;
  - a 52-week Treatment Period;
  - and a 24-week Follow-up Period
  The study aims to randomised approximately 540 participants globally

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  21/FT/0104

• Date of REC Opinion

  4 Oct 2021

• REC opinion

  Further Information Favourable Opinion