Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

• Status: Recruiting
• Trial end date: 2024-06-25
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Iqvia Pty Ltd

Criteria

Inclusion Criteria:

Inclusion CriteriaErythematosus

1. 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

2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening

3. BILAG2004 with at least 1 of the following:

1. BILAG2004 level A disease in ≥ 1 organ system

2. BILAG2004 level B disease in ≥ 2 organ systems

4. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening

5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,

6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.

Exclusion Criteria:

7. Active severe or unstable neuropsychiatric SLE

8. Active severe SLE-driven renal disease

9. 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.

10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).

11. 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.

12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody

13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),

14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.

15. History of cancer, apart from:

1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1)

2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).