A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

Study identifier:CD-IA-MEDI-545-1067

ClinicalTrials.gov identifier:NCT01283139

EudraCT identifier:2010-024069-30

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 2

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

834

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 31 Mar 2011
Primary Completion Date: 14 Nov 2013
Study Completion Date: 17 Apr 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2018 by MedImmune, LLC

Sponsors

MedImmune, LLC

Collaborators

-

Inclusion and exclusion criteria