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) (ILLUMINATE-2) - ILLUMINATE-2

• Conditions: Systemic Lupus Erythematosus (SLE); MedDRA version: 14.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-022100-42-HU
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-13
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1140

Inclusion Criteria

[1] Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
[2] Have positive antinuclear antibodies (ANA)
[3] Agree not to become pregnant throughout the course of the trial
[4] Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1026
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114

Exclusion Criteria

[1] Have active severe Lupus kidney disease
[2] Have active Central Nervous System or peripheral neurologic disease
[3] Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
[4] Have active or recent infection within 30 days of screening
[5] Have had a serious infection within 90 days of randomization
[6] Have evidence or test positive for Hepatitis B
[7] Have Hepatitis C
[8] Are human immunodeficiency virus (HIV) positive
[9] Have evidence of active or latent tuberculosis (TB)
[10] Presence of significant laboratory abnormalities at screening
[11] 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
[12] Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
[13] Have changed your dose of antimalarial drug in the past 30 days
[14] Have changed your dose of immunosuppressive drug in the past 90 days
[15] Have previously received rituximab

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified