A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- JPRN-jRCT2080220984
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Patients must have previously met 4 or more of the 11 revised ACR criteria
-Have positive antinuclear antibody test (ANA) at 1:80 serum dilute or more in the past or at screening
-Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score 6 or more
-Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
-Have received the following medications within 28 days before Visit 2 (Day 1):
- Systemic cyclophosphamide at any dose
- Cyclosporine at any dose
- Tacrolimus at any dose
- Thalidomide at any dose
- Mycophenolate mofetil >2 g/day
- Methotrexate >15 mg/week
- Azathioprine >2 mg/kg/day
-Women who have a positive pregnancy test (serum hCG) at Visit 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method