A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

• Status: Completed
• Trial end date: 2016-07-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: MedImmune LLC
• Treatments: Antibodies, Monoclonal; Sifalimumab

Criteria

Inclusion Criteria:

• Patients must have previously met ≥4 of the 11 revised ACR criteria

• Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute 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

Exclusion Criteria:

• 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