A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Anifrolumab 300 mg; Anifrolumab 1000 mg; Placebo
Intervention description: Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.; Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.; Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 626.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MEDI-546; Anifrolumab; Systemic Lupus Erythematosus

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 inadequate response to standard of care treatment for SLE.
    

Eligibility criteria:

        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 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 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

          -  Participants with significant hematologic abnormalities.