A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Sifalimumab 200 mg; Sifalimumab 600 mg; Sifalimumab 1,200 mg; Placebo
Intervention description: Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.; Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.; Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.; IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks
Intervention MeSH terms: Sifalimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 834.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: SLE; Systemic Lupus Erythematosus; Sifalimumab; MEDI-545

Summary:

      To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with
      moderately to severely active Systemic Lupus Erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR)
        criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody
        (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease
        history of SLE greater than or equal to (>=) 24 weeks at screening - Weight more than (>)
        40 kilogram (kg) - Currently receiving stable dose of oral prednisone 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 within 6 months of
        randomization - Female subjects must be willing to avoid pregnancy - Negative 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 - Herpes Zoster within 3 months of
        screening - History of cancer other than basal cancer or cervical cancer treated with
        apparent success >=1 year prior to randomization - Receipt of a biologic agent within 5
        half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer)
        prior to screening - Live or attenuated vaccine within 4 weeks prior to screening -
        Subjects with substance abuse - Subjects with significant hematologic abnormalities.