Lupus Foundation of America Inc.

Study Spotlight

Spotlight on: The ILLUMINATE Program

Study Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)

Sponsor: Eli Lilly and Company

Purpose: To confirm the clinical efficacy of the investigational treatment LY2127399 when administered with standard of care therapy in subjects with active systemic lupus erythematosus (SLE)

Eligibility criteria: Men and women, at least 18 years old

Key Inclusion Criteria - Individuals may be eligible if they are:

A diagnosis of systemic lupus erythematosus

Positive antinuclear antibodies (ANA)

Evidence of systemic disease activity (SELENA SLEDAI score≥6)

Key Exclusion Criteria - Individuals may be excluded if they:

Active lupus nephritis (kidney disease

Active central nervous system (CNS) or peripheral neurologic disease

Received exclusionary medications within a defined timeframe prior to randomization:

• intravenous immunoglobulin (IVIg) (past 180 days)
• oral corticosteroids (>40 mg prednisone or equivalent in past 30 days)
• antimalarial drugs (adjustment within past 30 days)
• immunosuppressive drugs (started in past 90 days or adjusted in past 30 days)
• ritixumab or other B cell targeted therapies any time previously
• biologic DMARDS (past 90 days)
• other biologic therapies (past 5 half-lives)
  

Study Type: Interventional - Participants will receive study treatment with either one of two doses of the investigational study drug or inactive placebo every 2 weeks for up to 1 year. Regardless of the treatment group to which a subject is randomly assigned, they will administer the study medication as an injection under the skin every 2 weeks. Standard of care therapies for lupus (corticosteroids, non-steroidal anti-inflammatory drugs [NSAIDs], antimalarials and immunosuppressants) are permitted during the study (with some restrictions in dose adjustments).

Locations: Over 200 physician offices for ILLUMINATE 1 and ILLUMINATE 2 throughout the United States.

Contact: www.illuminatestudy.com