A Randomized, DB, PC, Phase 3 Study of Baricitinib in Patients with

Systemic Lupus Erythematosus (SLE)

Main Inclusion: 

  • Have SLE meeting 4 of 11 Revised SLE 1997 UPDATED criteria –OR- having met at least 4 of the 2012 SLICC classification criteria (Petri et al. 2012), at least 1 clinical criterion and 1 immunology criterion prior to randomization.
  • Have + antinuclear antibody (ANA; titer ≥1:80), and/or a + anti-dsDNA, and/or a + anti-Smith (anti-Sm).
  • Total SLEDAI-2K score ≥6 during screening / a clinical SLEDAI-2K score ≥4 at Baseline (Visit 2).
  • 1 BILAG A score or 2 BILAG B scores during the screening period.
  • SOC therapy with at least one of the following:
  • A single antimalarial (such as hydroxychloroquine)
  • A single immunosuppressant (MTX, AZA, MMF, Plaquenil, SSZ, ARA, Prograf)
  • An oral corticosteroid, prednisone ≤ 40 mg/day prior to screening
  • If no AM or IS, corticosteroid must be ≥ 7.5 mg/day

Main Exclusion:

  • Lupus Nephritis defined clinically and/or by histologic DPGN, or urine p/c ratio >200 mg/mmol
  • or eGFR <40 mL/min/.
  • Active CNS lupus.
  • Other CTD such as RA, SpA, Crohn’s disease, UC, or PsA; secondary Sjogren’s syndrome not excluded.
  • (VTE [DVT/PE]) within 12 weeks of screening, MI, unstable ischemic heart disease, stroke,
  • or NYHA Stage III/IV heart failure.
  • Recurrent (≥ 2) VTE.
  • Have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years prior to randomization.
  • The following may be exempted:
  • Patients with cervical carcinoma in situ that has been resected.
  • Patients with basal cell or squamous epithelial skin cancers that have
  • been completely resected.
  • (IV), (IM), (IA) corticosteroids within 6 weeks of screening (Visit 1).
  • Any prior RA/PsA Biologics within 4 weeks of screening, Cytoxan (12 weeks), RTX (24 weeks).

 Advantage for Patients:

  • Active drug 2/3 for one year
  • 3 year extension study (JAIM) available.