Status:
ACTIVE_NOT_RECRUITING
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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
Detailed Description
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2026
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT04877691
Start Date
June 8 2021
End Date
November 18 2026
Last Update
November 25 2025
Active Locations (140)
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1
Research Site
Birmingham, Alabama, United States, 35233
2
Research Site
Paradise Valley, Arizona, United States, 85253
3
Research Site
Phoenix, Arizona, United States, 85032
4
Research Site
El Cajon, California, United States, 92020