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Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Sponsor: AstraZeneca
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
Official title: A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
367
Start Date
2021-06-08
Completion Date
2026-11-06
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
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
Locations (140)
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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
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Valencia, Spain
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Muang, Thailand
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Rachathewi, Thailand
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhia, Ukraine
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Doncaster, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom