Overview

This trial is active, not recruiting.

Conditions systemic lupus erythematosus, connective tissue disease, autoimmune disease
Treatments ly2127399, placebo every 2 weeks, placebo every 4 weeks
Phase phase 3
Sponsor Eli Lilly and Company
Start date January 2011
End date August 2014
Trial size 1140 participants
Trial identifier NCT01205438, 13653, H9B-MC-BCDT

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ly2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
(Experimental)
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
ly2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
(Placebo Comparator)
placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.

Primary Outcomes

Measure
Proportion of patients achieving an SLE Responder Index response at week 52
time frame: 52 weeks

Secondary Outcomes

Measure
Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52
time frame: 52 weeks
Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level
time frame: Baseline, 52 weeks
Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score
time frame: Baseline, 52 weeks
Time to first severe SLE flare (SFI)
time frame: Baseline through 52 weeks
Change from baseline to 52 week endpoint in Physician's Global Assessment (PGA)
time frame: Baseline, 52 weeks
Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQOL) composite and domain scores
time frame: Baseline, 52 weeks
Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks
time frame: 52 weeks
Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores
time frame: Baseline, 52 weeks
Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares
time frame: Baseline through 52 weeks
Proportion of patients with an increase in corticosteroids dose at 52 weeks
time frame: 52 weeks
Change from baseline to 52 weeks endpoint in Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity score
time frame: Baseline, 52 weeks
Change from baseline to 52 week endpoint BILAG numeric scores
time frame: Baseline, 52 weeks
Proportion of patients achieving a response as measured by modified SLE Responder Index (SRI) with no BILAG A or no more than 1 BILAG B organ domain flares at 52 weeks
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria - Have positive antinuclear antibodies (ANA) - Agree not to become pregnant throughout the course of the trial - Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score at 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

Additional Information

Official 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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.