A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

October 31, 2010

Conditions
DERMATOMYOSITIS OR POLYMYOSITIS
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 12 weeks.~Thereafter, subjects will receive MEDI-545, at the dose specified in the dose cohort they are assigned, every 2 weeks for an additional 12 weeks."

Trial Locations (14)

11042

Research Site, Lake Success

16635

Research Site, Duncansville

21224

Research Site, Baltimore

21502

Research Site, Cumberland

33136

Research Site, Miami

33334

Research Site, Fort Lauderdale

47714

Research Site, Evansville

66160

Research Site, Kansas City

85258

Research Site, Scottsdale

90606

Research Site, Whittier

94305

Research Site, Stanford

97239

Research Site, Portland

02115

Research Site, Boston

03756

Research Site, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY