A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus

PHASE1CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

July 31, 2010

Study Completion Date

September 30, 2010

Conditions
Lupus
Interventions
BIOLOGICAL

MEDI 545

"MEDI-545 is supplied as a sterile liquid containing 0.75 mL of MEDI-545 solution at a concentration of 100 mg/mL in a 3 mL single-use glass vial.~Dosage, frequency and duration: MEDI-545 (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."

OTHER

Placebo

"Dosage form: Placebo is supplied as a sterile liquid containing a 0.75 mL solution in a 3 mL single-use vial.~Dosage, frequency and duration: Placebo (0.3, 1.0, 3.0, or 10.0 mg/kg) will be administered via infusion over at least 60 minutes every 2 weeks for 26 weeks."

Trial Locations (23)

10003

Research Site, New York

10021

Research Site, New York

11030

Research Site, Manhasset

20892

Research Site, Bethesda

21205

Research Site, Baltimore

27858

Research Site, Greenville

33334

Research Site, Fort Lauderdale

33614

Research Site, Tampa

34474

Research Site, Ocala

36207

Research Site, Anniston

37765

Research Site, Clearwater

71130

Research Site, Shreveport

75235

Research Site, Dallas

90048

Research Site, Los Angeles

97223

Research Site, Portland

92037-0943

Research Site, La Jolla

Unknown

Research Site, Oklahoma City

Research Site, Buenos Aires

Research Site, São Paulo

Research Site, Santiago

75390-8577

Research Site, Dallas

T4000AXXL

Research Site, San Miguel de Tucumán

80060-240

Research Site, Curitiba

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY