ISLAND-SLE: LY3471851 in Adults with Systematic Lupus Erythematosus

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus

• IRAS ID

  286848

• Contact name

  David Pascal D'Cruz

• Contact email

  david.d'cruz@kcl.ac.uk

• Sponsor organisation

  Eli Lilly & Company

• Eudract number

  2019-003323-38

• Duration of Study in the UK

  0 years, 9 months, 15 days

• Research summary

  This study is investigating the use of a research drug currently known as LY-3471851 in the treatment of Systematic Lupus Erythematosus (SLE).

  SLE is a long-lasting, devastating disease in which body’s own immunity system is compromised because of an imbalance of its various component cells and this can affect multiple organ systems. LY-3471851 is proposed to restore this balance and thereby improving immune self-tolerance required to manage SLE.
  
  The existing treatment for SLE varies widely and currently includes the use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anti-malarial medication, cytotoxic agents, and immunosuppressants. Patients with SLE are in need of better treatment options.

  This Phase 2 study will evaluate the efficacy and safety of LY-3471851 in approximately 280 adult SLE patients between the ages of 18 to 65 years old from around the world with at least 3 participants selected from UK. LY-3471851 will be administered as subcutaneous injection every 2 weeks (maximum 12 doses). Patients will be enrolled in the study in such a way that four groups of approximately 70 participants will receive 12 doses of either 300ug or 900ug or 1800ug of LY-3471851 or a similar looking placebo. Neither the treating physician nor the participant will know what dose strength they are receiving during the study participation to avoid any bias. All participants will be allowed to continue with their already ongoing standard of care therapy at the beginning of their participation.

  Results of this study will be used to guide the dose selection for future research and to further characterize the benefit/risk profile of LY3471851.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  20/NE/0206

• Date of REC Opinion

  6 Nov 2020

• REC opinion

  Further Information Unfavourable Opinion