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Title Open label phase 2 pilot trial of oral tofacitinib in adult subjects with discoid lupus erythematosus (DLE) and systemic Lupus erythematosus (SLE)
Therapeutic Area Lupus Erythematosus
Principal Investigator David Rosmarin, MD
Min Age 18 Years
Max Age 65 Years
Gender All
Contact Nicole Dumont
617 636-7462
More Information


Open label phase 2 proof-of-concept trial of oral tofacitinib in adult patients with discoid lupus erythematosus (DLE) lesions and systemic lupus erythematosus (SLE).

Study Details

Inclusion Criteria

  • Adults 18 years to ≥ 65 years of age with clinical diagnosis of DLE (and at least half of patients with diagnosis of SLE)
  • Have a diagnosis of biopsy proven DLE for at least 6 months prior to Visits 1 (Baseline/Day 1)
  • At Screening and Visit 1 (Baseline/Day 1) have had DLE covering at least 5% of total body surface area (BSA) or SLE with DLE covering at least 2% of BSA as determined by hand print method (one palm is equivalent to 1% BSA)

Exclusion Criteria

  • Other skin conditions at Baseline that would interfere with evaluation of DLE
  • History of infection requiring hospitalization, parenteral antimicrobial therapy within 6 months prior to first dose of study drug or history of infection requiring antimicrobial therapy within 2 weeks prior to first dose of study drug
  • Concomitant use of moderate to potent inhibitors and inducers of CYP3A4/5

Study Requirements

6 month duration of study treatment + 28 days screening window + 1 month follow-up period resulting in total duration of up to 8 months with 9 visits to site.