Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

April 20, 2012

Primary Completion Date

August 19, 2014

Study Completion Date

February 21, 2017

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

MEDI-546

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

DRUG

MEDI-546

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

DRUG

MEDI-546

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.

Trial Locations (6)

260-8677

Research Site, Chiba

104-8560

Research Site, Chūōku

143-8541

Research Site, Ōta-ku

980-8574

Research Site, Sendai

329-0498

Research Site, Shimotsuke-shi

160-8582

Research Site, Shinjuku-ku

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

MedImmune LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY