A Study of LY2127399 in Patients With Systemic Lupus Erythematosus | Completed
A Study of LY2127399 in Patients With Systemic Lupus Erythematosus
Health Conditions
  • Systemic Lupus Erythematosus
  • Connective Tissue Disease
  • Autoimmune Disease
Completed
Recruitment Status
NCT01205438
Primary Trial ID Number
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.
Primary Outcome Measures
  • Proportion of patients achieving an SLE Responder Index response at week 52; 52 weeks
Secondary Outcome Measures
  • Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52; 52 weeks; Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level; Baseline, 52 weeks; Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score; Baseline, 52 weeks; Time to first severe SLE flare (SFI); Baseline through 52 weeks; Change from baseline to 52 week endpoint in Physician's Global Assessment (PGA); Baseline, 52 weeks; Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQOL) composite and domain scores; Baseline, 52 weeks; Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks; 52 weeks; Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores; Baseline, 52 weeks; Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares; Baseline through 52 weeks; Proportion of patients with an increase in corticosteroids dose at 52 weeks; 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; Baseline, 52 weeks; Change from baseline to 52 week endpoint BILAG numeric scores; 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; 52 weeks
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United States; Australia; Brazil; Canada; Ecuador; France; Hungary; India; Israel; Latvia; Malaysia; Mexico; New Zealand; Romania; Russian Federation; Serbia; South Africa; Spain; Taiwan; Tunisia; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; LY2127399; 120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug; [LY2127399 every 2 weeks, LY 2127399 every 4 weeks]; Drug; Placebo every 2 weeks; Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.; [Placebo]; Drug; Placebo every 4 weeks; Administered via subcutaneous injection for 52 weeks.; [LY 2127399 every 4 weeks]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific 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)
Secondary Trial Identifying Number
H9B-MC-BCDT
Website
Sorry, this information is not available
Study Funded By
Eli Lilly and Company
Funder Type
Sorry, this information is not available
Study Sponsored By
Eli Lilly and Company
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

17 Sep 2010

Last Updated

26 Jun 2015

Date Record Refreshed on UKCTG

31 Jul 2015