For Healthcare Professionals

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

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About the study

The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
  2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
  3. BILAG2004 with at least 1 of the following:
  1. BILAG2004 level A disease in ≥ 1 organ system
  2. BILAG2004 level B disease in ≥ 2 organ systems
  3. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
  4. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
  5. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

EXCLUSION CRITERIA

Exclusion Criteria:

  • Active severe or unstable neuropsychiatric SLE
  • Active severe SLE-driven renal disease
  • History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
  • History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
  • Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
  • At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
  • Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
  • Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
  • History of cancer, apart from:
    1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
    2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).
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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall 1-877-240-9479Email iconEmail Study Center

    Study Details


    Contition

    Systemic Lupus Erythematosus

    Age

    18 - 70

    Phase

    PHASE3

    Participants Needed

    360

    Est. Completion Date

    Dec 11, 2026

    Treatment Type

    INTERVENTIONAL


    Sponsor

    AstraZeneca

    ClinicalTrials.gov NCT Identifier

    NCT04877691

    Study Number

    D3465C00001

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