Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

About

Brief 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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

70 Years

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.
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).