A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
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:
Exclusion Criteria:
Summerville, South Carolina 29486, United States
CABA, Buenos Aires C1046AAQ, Argentina
Ciudad de Buenos Aires, Buenos Aires C1111AAH, Argentina
Buenos Aires, Ciudad Autonoma de Buenos Aire C1431FWO, Argentina
CABA, Ciudad Autónoma de Buenos Aire C1430EGF, Argentina
SAN M. de Tucuman, Tucumán Province T4000AXL, Argentina
Ciudad Autonoma Buenos Aires, C1181AAX, Argentina
Bogota, Cundinamarca, Colombia
Bogotá, Cundinamarca, Colombia
Hyderabad, Andhra Pradesh 500003, India
Nashik, Maharashtra 422101, India
Kita-gun, Kagawa-ken 761-0793, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Chuo-Ku, Tokyo 104 8560, Japan
Meguro-ku, Tokyo 153-8515, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Shinjuku-Ku, Tokyo 160-8582, Japan
Quenzon City, 1102, Philippines
Wroclaw, Lower Silesian Voivodeship 53224, Poland
Bialystok, Podlaskie Voivodeship 15-077, Poland
Bydgoszcz, 85-168, Poland
Bucureti, 014461, Romania
Muckleneuk, Pretoria 0002, South Africa
Seocho-Gu, Seoul 06591, South Korea