A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Status: | Completed |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | January 2012 |
End Date: | April 2015 |
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus
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 inadequate response to standard of care treatment for SLE.
placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus
(SLE) with an inadequate response to standard of care treatment for SLE.
Inclusion Criteria:
- 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 subjects 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 Criteria:
- 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
- Subjects with significant hematologic abnormalities
We found this trial at
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