Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID: NCT04877691
Run by: AstraZeneca
People needed: 367
Starts: 2021-06-08
Expected to finish: 2026-11-06
Last updated by the study team: 2026-07-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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:
Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)
Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Where it is running

Research Site — Paradise Valley, Arizona, United States
Research Site — Phoenix, Arizona, United States
Research Site — El Cajon, California, United States
Research Site — Fullerton, California, United States
Research Site — Hemet, California, United States
Research Site — La Mesa, California, United States
Research Site — Los Angeles, California, United States
Research Site — Menifee, California, United States
Research Site — Upland, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Brandon, Florida, United States
Research Site — Clearwater, Florida, United States
Research Site — Clearwater, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Idaho Falls, Idaho, United States
Research Site — Flint, Michigan, United States
Research Site — Lansing, Michigan, United States
Research Site — Newark, New Jersey, United States
Research Site — Las Cruces, New Mexico, United States
Research Site — Brooklyn, New York, United States
Research Site — Manhasset, New York, United States
Research Site — New York, New York, United States
Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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