Active — Not RecruitingPhase 3

Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

United States367 participantsStarted 2021-06-08

Plain-language summary

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

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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
✓. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
✓. BILAG2004 with at least 1 of the following:
✓. BILAG2004 level A disease in ≥ 1 organ system
✓. BILAG2004 level B disease in ≥ 2 organ systems
✓. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
✓. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
✓. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

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.
✕0. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
✕1. 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.
✕2. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
✕3. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
✕4. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.

What they're measuring

British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response

Timeframe: At week 52

Trial details

NCT IDNCT04877691

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-22

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