EMERALD

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus

• IRAS ID

  1007419

• Contact name

  Matthew Stagray

• Contact email

  clinicaltrials@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2021-006378-22

• Research summary

  Systemic lupus erythematosus (SLE) is an autoimmune disease that can affect many parts of the body, but frequently involves the joints, skin, kidneys, blood cells, and mucus membranes. The immune system attacks these tissues resulting in inflammation.

  Emerald (230LE306) is an extension to Topaz (230LE304) study. Only adult patients with SLE who completed Topaz can take part in this extension study. It is planned to involve approximately 280 sites globally in 32 countries. A total of approximately 864 participants of the Topaz study will be enrolled.

  The purpose of this study is to look at how safe BIIB059 (the study drug) is in terms of any medical problems known as “side effects”, and how the body handles receiving the study drug (tolerability), when given for a longer period of time. The study will also look at the following:
  • If the study drug can reduce disease activity and inflammation in people with active SLE, when given for a longer period of time.
  • Whether the study drug works in controlling SLE symptoms when used in addition to a standard lupus treatment.
  • Whether the body produces antibodies against the study drug.
  • How the body responds to the study drug, by looking at biomarkers.

  Depending on the treatment group patients were randomised to in the parent study, they will either continue to receive BIIB059 225 mg or BIIB059 450 mg, or initiate treatment with BIIB059 225 mg or BIIB059 450 mg. The There will be no use of placebo arm in this Long-Term Extension.

  The total study duration for each participant will be up to 180 weeks:
  • Dose-blind treatment period of 156 weeks (18 study visits and 23 dosing only visits)
  • Safety Follow-Up period of 24 weeks (up to 6 study visits)

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  23/LO/0250

• Date of REC Opinion

  16 Aug 2023

• REC opinion

  Further Information Favourable Opinion