Systemic Lupus Erythematosus
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have a clinical diagnosis of SLE at least 24 weeks prior to screening. - Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization. - Have a positive antinuclear antibody (ANA) (titer >=1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening. - Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6 during screening. - Have a clinical SLEDAI-2K score >=4 at randomization. - Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening. - Are receiving at least one of the following standard of care medications for SLE: - A single antimalarial at a stable dose for at least 8 weeks prior to screening - A single immunosuppressant at a stable dose for at least 8 weeks prior to screening - An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose =7.5 milligrams/day prednisone (or equivalent)
Exclusion criteria
Exclusion criteria: - Have severe active lupus nephritis. - Have active central nervous system (CNS) lupus. - Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. - Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection. - Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy SRI-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| other safety efficacy exploratory pharmacokinetics pharmacodynamics pharmacogenomics - | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed