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)
Status: Recruiting
Location: See all (216) locations...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 18 - 75 years old
• Body weight 40 kg - ≤ 100 kg
• Must have probable or definite diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
• Moderate or severe disease activity per core set measurements.
• Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
• No history of active tuberculosis or severe COVID-19.
• Male and female participants must follow contraception guidelines.
Locations
United States
California
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Irvine
Colorado
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Aurora
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Denver
Connecticut
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New Haven
Washington, D.c.
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Washington D.c.
Florida
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Boca Raton
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Boynton Beach
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Gainesville
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Margate
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Miami
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Orlando
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Palm Beach Gardens
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Plant City
Georgia
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Atlanta
Illinois
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Willowbrook
Kansas
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Fairway
Massachusetts
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Boston
Maryland
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Baltimore
Michigan
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Ann Arbor
North Carolina
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Charlotte
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Charlotte
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Durham
New York
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Great Neck
Ohio
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Cleveland
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Middleburg Heights
Pennsylvania
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Pittsburgh
South Carolina
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Charleston
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Summerville
Texas
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Allen
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Colleyville
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El Paso
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North Richland Hills
Wisconsin
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Milwaukee
Other Locations
Argentina
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Buenos Aires
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Buenos Aires
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Caba
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Quilmes
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San Miguel De Tucumán
Australia
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Camperdown
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Nedlands
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New Lambton
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Southport
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Woodville South
Austria
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Graz
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Vienna
Belgium
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Ghent
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Leuven
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Merksem
Brazil
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Joinville
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Juiz De Fora
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Pelotas
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Porto Alegre
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Salvador
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Salvador
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São José Do Rio Preto
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São Paulo
Bulgaria
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Haskovo
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Plovdiv
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Plovdiv
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Sofia
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Stara Zagora
Canada
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Calgary
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Calgary
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Montreal
Chile
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Concepción
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Las Condes
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Osorno
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Santiago
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Santiago
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Santiago
China
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Beijing
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Beijing
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Beijing
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Beijing
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Chongqing
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Dongguan
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Guangzhou
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Guangzhou
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Hangzhou
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Hengyang
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Jining
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Nanjing
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Shanghai
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Shanghai
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Shanghai
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Shanghai
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Shijiazhuang
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Wenzhou
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Zhengzhou
Denmark
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Aarhus N
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Copenhagen
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Odense C
France
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Angers
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Brest
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Le Mans
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Lille
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Lyon
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Paris
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Paris
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Reims
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Rouen
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Strasbourg
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Toulouse
Germany
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Bad Nauheim
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Berlin
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Bonn
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Freiburg Im Breisgau
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Herne
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München
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Tübingen
Hungary
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Debrecen
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Szeged
India
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Ahmedabad
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Ahmedabad
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Dehradun
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Gurugram
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Hyderabad
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Kolkata
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Lucknow
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Mumbai
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Mumbai
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Mumbai
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Mysuru
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New Delhi
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Puducherry
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Secunderabad
Israel
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Afula
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Haifa
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Jerusalem
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Kfar Saba
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Ramat Gan
Italy
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Ancona
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Bari
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Catania
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Milan
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Milan
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Padua
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Palermo
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Pavia
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Pisa
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Roma
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Roma
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Roma
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Rozzano
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Siena
Japan
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Asahikawa-shi
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Bunkyō City
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Chiba
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Fukuoka
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Iruma-gun
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Kawachinagano-shi
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Kawasaki-shi
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Nagoya
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Nagoya
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Okayama
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Omura-shi
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Sendai
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Shinjuku-ku
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Tachikawa-shi
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Yotsukaido-shi
Mexico
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Culiacán
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D.f
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Guadalajara
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Guadalajara
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Guadalajara
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México
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México
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Mexico City
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Mexico City
Netherlands
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Amsterdam
Poland
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Bialystok
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Krakow
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Krakow
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Lodz
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Poznan
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Poznan
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Warsaw
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Warsaw
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Wroclaw
Puerto Rico
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Caguas
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San Juan
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Daejeon
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Seoul
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Seoul
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Seoul
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Seoul
Spain
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A Coruña
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Barcelona
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Barcelona
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Barcelona
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Córdoba
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L'hospitalet De Llobregat
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Madrid
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Madrid
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Sabadell
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Valladolid
Sweden
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Stockholm
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Uppsala
Taiwan
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Kaohsiung City
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Kaohsiung City
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New Taipei City
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Taichung
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Taichung
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Taipei
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Taoyuan District
United Kingdom
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Edinburgh
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London
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Wolverhampton
Viet Nam
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Hà Nội
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Hà Nội
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Hanoi
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Hanoi
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Hồ Chí Minh
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Ho Chi Minh City
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Hochiminh City
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Huế
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2028-08-04
Participants
Target number of participants: 240
Treatments
Experimental: Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly
Placebo_comparator: Placebo (subcutaneous weekly injection)
Matched placebo control subcutaneous injection once weekly
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca