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 Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,124
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving an SLE Responder Index Response at Week 52
Study Overview
Brief 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 participants with active SLE.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 a screening SELENA-SLEDAI score ≥
- •(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
Arms & Interventions
LY2127399 every 2 weeks
Intervention: LY2127399 (Drug)
LY2127399 every 4 weeks
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Intervention: LY2127399 (Drug)
LY2127399 every 4 weeks
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Intervention: Placebo every 4 weeks (Drug)
Placebo
Intervention: Placebo every 2 weeks (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving an SLE Responder Index Response at Week 52
Time Frame: 52 weeks
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
Secondary Outcomes
- Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level(Baseline, 52 weeks)
- Percentage of Participants 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 Endpoint in SELENA-SLEDAI Disease Activity Score(Baseline, 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)
- Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks(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)
- Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks(52 weeks)
- Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks(52 weeks)
- Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores(Baseline, 52 weeks)
- Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline(Baseline through 52 weeks)