Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
NCT ID: NCT04877691
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
367 participants
INTERVENTIONAL
2021-06-08
2026-11-06
Brief Summary
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Detailed Description
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Approximately 360 participants receiving SOC treatment will be randomised in a 1:1 ratio to receive a fixed subcutaneous dose of anifrolumab or placebo administered once weekly via an accessorized prefilled syringe and with the primary endpoint evaluated at Week 52. Subjects who complete Week 52 may enter into open-label extension (OLE). All patients who enter the OLE Period will receive a fixed subcutaneous dose of anifrolumab for up to 52 weeks. Study intervention will be administered SC via an accessorised prefilled syringe (aPFS).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Anifrolumab
Solution for injection in aPFS
Medi-546
Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration.
Placebo
Solution for injection in aPFS
Placebo
Solution for injection in aPFS
Interventions
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Medi-546
Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration.
Placebo
Solution for injection in aPFS
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
70 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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El Cajon, California, United States
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Fullerton, California, United States
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Hemet, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Menifee, California, United States
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Upland, California, United States
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Aurora, Colorado, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Idaho Falls, Idaho, United States
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Flint, Michigan, United States
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Lansing, Michigan, United States
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Newark, New Jersey, United States
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Las Cruces, New Mexico, United States
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Brooklyn, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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Potsdam, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Memphis, Tennessee, United States
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Grapevine, Texas, United States
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Ciudad de Buenos Aires, , Argentina
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La Plata, , Argentina
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Mendoza, , Argentina
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Pergamino, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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Salta, , Argentina
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San Isidro, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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San Miguel de Tucumán, , Argentina
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San Miguel de Tucumán, , Argentina
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Kardzhali, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Osorno, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Barranquilla, , Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Chía, , Colombia
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Montería, , Colombia
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Berlin, , Germany
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Cologne, , Germany
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Leipzig, , Germany
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Tübingen, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Chiba, , Japan
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Chūōku, , Japan
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Hamamatsu, , Japan
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Hiroshima, , Japan
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Itabashi-ku, , Japan
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Kita-gun, , Japan
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Kitakyushu-shi, , Japan
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Meguro-ku, , Japan
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Meguro-ku, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Sagamihara-shi, , Japan
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Sasebo-shi, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Chihuahua City, , Mexico
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Culiacán, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexicali, , Mexico
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Mérida, , Mexico
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Mérida, , Mexico
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México, , Mexico
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México, , Mexico
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México, , Mexico
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Quezon City, , Philippines
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Katowice, , Poland
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Kościan, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Nowa Sól, , Poland
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Ustroń, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
Research Site
Valencia, , Spain
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Muang, , Thailand
Research Site
Rachathewi, , Thailand
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Kyiv, , Ukraine
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Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
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Odesa, , Ukraine
Research Site
Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
Research Site
Zaporizhzhia, , Ukraine
Research Site
Doncaster, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Other Identifiers
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SZA64400
Identifier Type: -
Identifier Source: secondary_id
2020-004529-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3465C00001
Identifier Type: -
Identifier Source: org_study_id
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