Conditions: Systemic Lupus Erythematosus
Keywords: Japan Phase2 Safety Tolerability Systemic Lupus Erythematosus SLE, MEDI-546
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

Detailed description:
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)

Arms:
arm 1: MEDI-546 100 mg IV arm 2: MEDI-546 300 mg IV arm 3: MEDI-546 1000 mg IV

Interventions: intervention 1: MEDI-546 intervention 2: MEDI-546 intervention 3: MEDI-546
Intervention descriptions: intervention 1: Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks intervention 2: Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks intervention 3: Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.

Protocol document: