Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
Exclusion Criteria:
- 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).
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.
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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