An open-label study to evaluate the long-term safety of MEDI-546, for the treatment of SLE, in adults

Study identifier:CD-IA-MEDI-546-1145

ClinicalTrials.gov identifier:NCT01753193

EudraCT identifier:2012-004619-30

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus

Medical condition

Lupus Erythematosus, Systemic

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

218

Study type

Interventional

Age

18 Years - 68 Years

Date

Study Start Date: 28 Mar 2013

Primary Completion Date: 18 Jul 2018

Study Completion Date: 18 Jul 2018

Study design

Allocation: N/A
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2019 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Orlando, FL, United States, 32806

Location

Research Site

Upland, CA, United States, 91786

Location

Research Site

Tulsa, OK, United States, 74104

Location

Research Site

Barranquilla, Colombia, N/A

Location

Research Site

Chia, Colombia, N/A

Location

Research Site

Medellin, Colombia, N/A

Location

Research Site

Bogota, Colombia, N/A

Location

Research Site

New York, NY, United States, 10016

Arms	Assigned Interventions
Experimental: Anifrolumab Participants will receive IV infusion of anifrolumab 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter will receive 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.	Biological/Vaccine: Anifrolumab Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first. Other Name: MEDI-546

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

An open-label study to evaluate the long-term safety of MEDI-546, for the treatment of SLE, in adults

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Trial Results Summaries

Contacts

Contact