Status:
COMPLETED
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Lead Sponsor:
MedImmune LLC
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inad...
Detailed Description
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment regimens in adult ...
Eligibility Criteria
Inclusion
- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
- Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
- Weight greater than or equal to 40 kg
- Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
- No evidence of cervical malignancy on Pap smear within 2 years of randomization
- Female participants must be willing to avoid pregnancy
- Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.
Exclusion
- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of human immunodeficiency virus (HIV)
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
- Live or attenuated vaccine within 4 weeks prior to screening
- Participants with significant hematologic abnormalities.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT01438489
Start Date
January 1 2012
End Date
April 1 2015
Last Update
October 7 2016
Active Locations (79)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
La Jolla, California, United States
3
Research Site
La Palma, California, United States
4
Research Site
Long Beach, California, United States