A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Lilly

Status and phase: Completed; Phase 3

Conditions: Connective Tissue Disease; Autoimmune Disease; Systemic Lupus Erythematosus

Treatments: Drug: LY2127399; Drug: Placebo every 4 weeks; Drug: Placebo every 2 weeks; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196091

13656

H9B-MC -BCDS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,164 participants in 3 patient groups, including a placebo group

LY2127399 every 2 weeks

Experimental group

Description:

Administered SC

Treatment:

Drug: Standard of Care

Drug: LY2127399

LY2127399 every 4 wks

Experimental group

Description:

During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

Treatment:

Drug: Standard of Care

Drug: LY2127399

Drug: Placebo every 4 weeks

Placebo

Placebo Comparator group

Description:

Administered SC

Treatment:

Drug: Standard of Care

Drug: Placebo every 2 weeks