Systemic Lupus Erythematosus (SLE)
Conditions
Interventions
investigational material(s)
Generic name etc : Baricitinib
INN of investigational material : Baricitinib
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria. Have a positive antinuclear antibody (ANA) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening. Have a SLEDAI-2K score 4 or more based on clinical symptoms (not including lab values) at randomization. Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.
Exclusion criteria
Exclusion criteria: Have active severe lupus nephritis. Have active severe 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. Are currently receiving oral corticosteroids at doses >20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization. Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization. Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization. Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization. Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants who Achieve Remission of Arthritis and/or Rash defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: Week 24 ] [ Designated as safety issue: No ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants who Achieve SLE Responder Index 4 (SRI-4) Response [ Time Frame: Week 24 ] [ Designated as safety issue: No ] Change from Baseline in SLEDAI-2K Score [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ] Change from Baseline in Patient's Global Assessment of Disease Activity [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ] Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ] | — |
Outcome results
None listed