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A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Sponsor: AstraZeneca
Summary
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
Official title: A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-06-20
Completion Date
2029-04-09
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Locations (237)
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Phoenix, Arizona, United States
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Irvine, California, United States
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Aurora, Colorado, United States
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Denver, 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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Boynton Beach, Florida, United States
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Gainesville, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Plant City, Florida, United States
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Atlanta, Georgia, United States
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Willowbrook, Illinois, United States
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Fairway, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Sterling Heights, Michigan, United States
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Great Neck, 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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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Middleburg Heights, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Summerville, South Carolina, United States
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Allen, Texas, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Colleyville, Texas, United States
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El Paso, Texas, United States
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Galveston, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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North Richland Hills, Texas, United States
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Beckley, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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CABA, Argentina
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Ciudad de Buenos Aires, Argentina
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Quilmes, Argentina
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San Miguel de Tucumán, Argentina
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Camperdown, Australia
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Nedlands, Australia
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New Lambton, Australia
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Southport, Australia
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Woodville South, Australia
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Graz, Austria
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Vienna, Austria
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Ghent, Belgium
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Leuven, Belgium
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Merksem, Belgium
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Joinville, Brazil
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Juiz de Fora, Brazil
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Pelotas, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Haskovo, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Montreal, Quebec, Canada
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Concepción, Chile
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Las Condes, Chile
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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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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Chongqing, China
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Dongguan, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hengyang, China
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Jining, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Shijiazhuang, China