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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 25, 2009

Primary Completion Date

November 7, 2012

Study Completion Date

July 11, 2016

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

MEDI-545

"Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses."

DRUG

MEDI-545

"Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses"

DRUG

MEDI-545

"Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses."

DRUG

MEDI-545

"Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.~Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses."

DRUG

MEDI-545

"Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.~Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses"

DRUG

MEDI-545 600

"Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.~Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses."

Trial Locations (7)

260-8712

Research Site, Chiba

810-8563

Research Site, Fukuoka

920-8650

Research Site, Kanazawa

350-8550

Research Site, Kawagoe-shi

807-8555

Research Site, Kitakyushu-shi

060-8638

Research Site, Sapporo

160-8582

Research Site, Shinjuku-ku

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

MedImmune LLC

INDUSTRY

lead

AstraZeneca

INDUSTRY