At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 2 clinical trial evaluating MEDI-546 for Systemic Lupus Erythematosus. Completed, enrolled 17 participants across 6 sites.
Detailed Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
Study Details
Timeline
Interventions
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
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
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.