A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal; Antimalarials; Immunosuppressive Agents

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