MedTrace Logo

A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus

NCT00657189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2016-08-09

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.

Conditions

  • Lupus Erythematosus, Systemic
  • Lupus

Interventions

DRUG

MEDI-545

100 mg once; SC Placebo × 12 doses on other weeks

DRUG

MEDI-545

100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks

DRUG

MEDI-545

100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks

DRUG

MEDI-545

100 mg every week × 13 doses

DRUG

Placebo

SC Placebo every week × 13 doses

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Warren Greth, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00657189 on ClinicalTrials.gov