Phase 3
N=1,124
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus · Connective Tissue Disease · Autoimmune Disease
Bottom Line
View on ClinicalTrials.gov: NCT01205438 ↗Enrolled (actual)
1,124
Serious AEs
15.6%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Participants Achieving an SLE Responder Index Response at Week 52 — 38.5; 34.8; 27.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LY2127399 (Drug); Placebo every 2 weeks (Drug); Placebo every 4 weeks (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an SLE Responder Index Response at Week 52 |
38.5; 34.8; 27.7 | — |
| SECONDARY Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 |
21.2; 14.7; 11.5 | — |
| SECONDARY Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level |
-27.7; -26.4; -7.0 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score |
10.3; 10.4; 9.8; -4.9; -4.7; -3.6 | — |
| SECONDARY Time to First Severe SLE Flare (SFI) |
— | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA) |
-21.2; -19.2; -15.1 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores |
69.0; 66.2; 70.7; 72.7; 72.3; 74.0 | — |
| SECONDARY Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks |
32.8; 37.8; 42.8 | — |
| SECONDARY Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores |
-0.7; -0.5; -0.5 | — |
| SECONDARY Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares |
— | — |
| SECONDARY Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks |
4.7; 6.2; 5.9 | — |
| SECONDARY Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score |
-5.1; -4.8; -3.7 | — |
| SECONDARY Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline |
134; 144; 160 | — |
| SECONDARY 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 |
38.7; 34.8; 27.7 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01205438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.