MedTrace Logo

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

NCT00482989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2012-07-11

No results posted yet for this study

Summary

To evaluate the safety and tolerability of multiple IV doses of the MEDIMUNNE antibody in adult patients with SLE.

Conditions

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.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Warren Greth, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-07-31
Completion
2010-09-30

Countries

  • United States
  • Argentina
  • Brazil
  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00482989 on ClinicalTrials.gov