A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease
MeSH terms: Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases
Intervention: LY2127399; Placebo every 2 weeks; Placebo every 4 weeks; Standard of Care
Intervention description: 120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.; Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose; Administered via subcutaneous injection for 52 weeks.
Intervention MeSH terms: Antimalarials; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Immunosuppressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus; SLE; Systemic Lupus Erythematosis; autoimmune disease; LY2127399; Immune system disease

Summary:

      The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two
      different doses of LY2127399 administered in participants with active SLE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria

          -  Have positive antinuclear antibodies (ANA)

          -  Agree not to become pregnant throughout the course of the trial

          -  Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting
             all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

        Exclusion Criteria:

          -  Have active severe Lupus kidney disease

          -  Have active Central Nervous System or peripheral neurologic disease

          -  Have received intravenous immunoglobulin (IVIg) within 180 days of randomization

          -  Have active or recent infection within 30 days of screening

          -  Have had a serious infection within 90 days of randomization

          -  Have evidence or test positive for Hepatitis B

          -  Have Hepatitis C

          -  Are human immunodeficiency virus (HIV) positive

          -  Have evidence of active or latent tuberculosis (TB)

          -  Presence of significant laboratory abnormalities at screening

          -  Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or
             basal cell or squamous epithelial skin cell that were completely resected with no
             reoccurrence in the 3 yrs prior to randomization

          -  Have received greater than 40 mgs of prednisone or equivalent in the past 30 days

          -  Have changed your dose of antimalarial drug in the past 30 days

          -  Have changed your dose of immunosuppressive drug in the past 90 days

          -  Have previously received rituximab