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

Study identifier:MI-CP152

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients with Systemic Lupus Erythematosus

Medical condition

Lupus

Phase

Phase 1

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

183

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Jun 2007
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Sept 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2012 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria