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Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)
Sponsor: AstraZeneca
Summary
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.
Official title: A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
314
Start Date
2023-11-08
Completion Date
2028-04-05
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo (blinded)
matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label)
At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
Locations (151)
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Scottsdale, Arizona, United States
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Chula Vista, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Margate, Florida, United States
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South Miami, Florida, United States
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Tamarac, Florida, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Babylon, New York, United States
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New York, New York, United States
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Cincinnati, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Allen, Texas, United States
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Houston, Texas, United States
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Graz, Austria
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Innsbruck, Austria
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Vienna, Austria
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Ghent, Belgium
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Leuven, Belgium
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Canada
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Beijing, China
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Beijing, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Lanzhou, China
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Shanghai, China
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Shanghai, China
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Tianjin, China
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Bordeaux, France
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Brest, France
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Paris, France
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Paris, France
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Rennes, France
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Strasbourg, France
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Toulouse, France
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Freiburg im Breisgau, Germany
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Mainz, Germany
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Minden, Germany
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Münster, Germany
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Tübingen, Germany
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Ahmedabad, India
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Delhi, India
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Gurugram, India
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Hyderabad, India
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Kolkata, India
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Mumbai, India
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Mysuru, India
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New Delhi, India
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Pune, India
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Secunderabad, India
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Afula, Israel
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Haifa, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Ramat Gan, Israel
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Ancona, Italy
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Brescia, Italy
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Cona, Italy
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Milan, Italy
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Padova, Italy
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Roma, Italy
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Roma, Italy
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Roma, Italy
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Bunkyō City, Japan
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Fukuoka, Japan
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Iruma-Gun, Japan
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Kanazawa, Japan
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Maebashi, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Sapporo, Japan
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Sendai, Japan
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Shinjuku-ku, Japan
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Shinjuku-ku, Japan
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Suita-shi, Japan
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Takatsuki-shi, Japan
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Toyoake-shi, Japan
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Yokohama, Japan
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Seremban, Malaysia
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Chihuahua City, Mexico
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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San Luis Potosí City, Mexico
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San Luis Potosí City, Mexico
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Groningen, Netherlands
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Bydgoszcz, Poland
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Krakow, Poland
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Krakow, Poland
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Lodz, Poland
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Sosnowiec, Poland
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Warsaw, Poland
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Bucharest, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Parktown, South Africa
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Pretoria, South Africa
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Busan, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Valencia, Spain
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Valencia, Spain
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Center, Turkey (Türkiye)
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Kazımkarabekir, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Cannock, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Sheffield, United Kingdom
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Hanoi, Vietnam
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Hà Nội, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Hochiminh, Vietnam