A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Baricitinib; Placebo
Intervention description: Administered orally.; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 778.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE

Summary:

      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).
    

Eligibility 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 ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks
                  prior to screening. If the participant is not receiving an antimalarial or
                  immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day
                  prednisone (or equivalent)

        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.