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Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: Medi-546, Placebo

Countries: United States, Argentina, Bulgaria, Chile, Colombia, Germany, Hungary, Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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).

Locations (140)

Birmingham, Alabama, United States
Paradise Valley, Arizona, United States
Phoenix, Arizona, United States
El Cajon, California, United States
Fullerton, California, United States
Hemet, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Menifee, California, United States
Upland, California, United States
Aurora, Colorado, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Idaho Falls, Idaho, United States
Flint, Michigan, United States
Lansing, Michigan, United States
Newark, New Jersey, United States
Las Cruces, New Mexico, United States
Brooklyn, New York, United States
Manhasset, New York, United States
New York, New York, United States
Potsdam, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
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