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).
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.
