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)
Start Date
6/20/2024
Completion Date
8/4/2028
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 Criteria
Age Range: 18 years to 75 years
Interventions
Anifrolumab (blinded)
Placebo
Anifrolumab (unblinded, open label)
Conditions
Locations
Research Site
Phoenix, Arizona 85032
United States
Research Site
Irvine, California 92617
United States
Research Site
Aurora, Colorado 80045
United States
Research Site
Denver, Colorado 80230
United States
Research Site
New Haven, Connecticut 06519
United States
Research Site
Washington D.C., District of Columbia 20037
United States
Research Site
Boca Raton, Florida 33486
United States
Research Site
Boynton Beach, Florida 33472
United States
Research Site
Gainesville, Florida 32603
United States
Research Site
Margate, Florida 33063
United States
Research Site
Miami, Florida 33126
United States
Research Site
Miami, Florida 33133
United States
Research Site
Orlando, Florida 32819
United States
Research Site
Palm Beach Gardens, Florida 33410
United States
Research Site
Plant City, Florida 33563
United States
Research Site
Atlanta, Georgia 30322
United States
Research Site
Willowbrook, Illinois 60527
United States
Research Site
Fairway, Kansas 66205
United States
Research Site
Baltimore, Maryland 21224
United States
Research Site
Boston, Massachusetts 02115
United States
Research Site
Ann Arbor, Michigan 48109
United States
Research Site
Sterling Heights, Michigan 48313
United States
Research Site
Great Neck, New York 11021
United States
Research Site
Charlotte, North Carolina 28207
United States
Research Site
Charlotte, North Carolina 28211
United States
Research Site
Durham, North Carolina 27710
United States
Research Site
Cleveland, Ohio 44195
United States
Research Site
Middleburg Heights, Ohio 44130
United States
Research Site
Philadelphia, Pennsylvania 19107
United States
Research Site
Pittsburgh, Pennsylvania 15213
United States
Research Site
Charleston, South Carolina 29425
United States
Research Site
Summerville, South Carolina 29486
United States
Research Site
Allen, Texas 75013
United States
Research Site
Amarillo, Texas 79124
United States
Research Site
Austin, Texas 78759
United States
Research Site
Colleyville, Texas 76034
United States
Research Site
El Paso, Texas 79902
United States
Research Site
Galveston, Texas 77555
United States
Research Site
Harlingen, Texas 78550
United States
Research Site
Houston, Texas 77030
United States
Research Site
North Richland Hills, Texas 76180
United States
Research Site
Beckley, West Virginia 25801
United States
Research Site
Milwaukee, Wisconsin 53226
United States
Research Site
Buenos Aires, C1180AAX
Argentina
Research Site
CABA, C1431FWO
Argentina
Research Site
Ciudad de Buenos Aires, C1405BCH
Argentina
Research Site
Quilmes, B1878GEG
Argentina
Research Site
San Miguel de Tucumán, T4000AXL
Argentina
Research Site
Camperdown, 2050
Australia
Research Site
Nedlands, 6009
Australia
Research Site
New Lambton, 2310
Australia
Research Site
Southport, 4222
Australia
Research Site
Woodville South, 5011
Australia
Research Site
Graz, 8036
Austria
Research Site
Vienna, 1090
Austria
Research Site
Ghent, 9000
Belgium
Research Site
Leuven, 3000
Belgium
Research Site
Merksem, B-2170
Belgium
Research Site
Joinville, 89202-190
Brazil
Research Site
Juiz de Fora, 36010 570
Brazil
Research Site
Pelotas, 96040-010
Brazil
Research Site
Porto Alegre, 90620-110
Brazil
Research Site
Salvador, 40150-150
Brazil
Research Site
Salvador, 41253-190
Brazil
Research Site
São José do Rio Preto, 15090-000
Brazil
Research Site
São Paulo, 01233-907
Brazil
Research Site
São Paulo, 5403-000
Brazil
Research Site
Haskovo, 6304
Bulgaria
Research Site
Plovdiv, 4001
Bulgaria
Research Site
Plovdiv, 4002
Bulgaria
Research Site
Plovdiv, 4002
Bulgaria
Research Site
Rousse, 7000
Bulgaria
Research Site
Sofia, 1680
Bulgaria
Research Site
Stara Zagora, 6003
Bulgaria
Research Site
Calgary, Alberta T2N 4L7
Canada
Research Site
Calgary, Alberta T3M1M4
Canada
Research Site
Montreal, Quebec H3T 1E2
Canada
Research Site
Concepción, 4070022
Chile
Research Site
Las Condes, 7560908
Chile
Research Site
Osorno, 200025
Chile
Research Site
Santiago, 7691236
Chile
Research Site
Santiago, 8330034
Chile
Research Site
Santiago, 8420383
Chile
Research Site
Beijing, 100029
China
Research Site
Beijing, 100044
China
Research Site
Beijing, 100191
China
Research Site
Beijing, CN-100730
China
Research Site
Chongqing, 402260
China
Research Site
Dongguan, 523009
China
Research Site
Guangzhou, 510317
China
Research Site
Guangzhou, 510630
China
Research Site
Hangzhou, 310014
China
Research Site
Hengyang, 421001
China
Research Site
Jining, 272011
China
Research Site
Nanjing, 210029
China
Research Site
Shanghai, 200025
China
Research Site
Shanghai, 200032
China
Research Site
Shanghai, 200040
China
Research Site
Shanghai,
China
Research Site
Shijiazhuang, 050001
China
Research Site
Wenzhou, 325000
China
Research Site
Zhengzhou, 450052
China
Research Site
Prague, 12850
Czechia
Research Site
Aarhus N, 8200
Denmark
Research Site
Copenhagen, 2100
Denmark
Research Site
Odense C, 5000
Denmark
Research Site
Angers, 49033
France
Research Site
Brest, 29609
France
Research Site
Le Mans, 72037
France
Research Site
Lille, 59037
France
Research Site
Lyon, 69437
France
Research Site
Paris, 75010
France
Research Site
Paris, 75651
France
Research Site
Reims, 51100
France
Research Site
Rouen, 76000
France
Research Site
Strasbourg, 67098
France
Research Site
Toulouse, 31059
France
Research Site
Bad Nauheim, 61231
Germany
Research Site
Berlin, 10117
Germany
Research Site
Bonn, 53127
Germany
Research Site
Freiburg im Breisgau, 79106
Germany
Research Site
Herne, 44649
Germany
Research Site
München, 80336
Germany
Research Site
Tübingen, 72076
Germany
Research Site
Budapest, 1023
Hungary
Research Site
Debrecen, 4032
Hungary
Research Site
Szeged, 6725
Hungary
Research Site
Ahmedabad, 380006
India
Research Site
Ahmedabad, 382421
India
Research Site
Dehradun, 248016
India
Research Site
Delhi, 110029
India
Research Site
Gurugram, 122001
India
Research Site
Hyderabad, 500082
India
Research Site
Kolkata, 700020
India
Research Site
Lucknow, 226030
India
Research Site
Mumbai, 400 078
India
Research Site
Mumbai, 400012
India
Research Site
Mumbai, 400053
India
Research Site
Mysuru, 570004
India
Research Site
New Delhi, 110060
India
Research Site
Puducherry, 605006
India
Research Site
Secunderabad, 500003
India
Research Site
Afula, 18101
Israel
Research Site
Haifa, 31048
Israel
Research Site
Haifa, 34362
Israel
Research Site
Jerusalem, 91120
Israel
Research Site
Kfar Saba, 4428164
Israel
Research Site
Ramat Gan, 52621
Israel
Research Site
Ancona, 60126
Italy
Research Site
Bari, 70124
Italy
Research Site
Catania, 95100
Italy
Research Site
Milan, 20132
Italy
Research Site
Milan, 20161
Italy
Research Site
Padova, 35128
Italy
Research Site
Palermo, 90127
Italy
Research Site
Pavia, 27100
Italy
Research Site
Pisa, 56126
Italy
Research Site
Roma, 00128
Italy
Research Site
Roma, 00161
Italy
Research Site
Roma, 00189
Italy
Research Site
Rozzano, 20089
Italy
Research Site
Siena, 53100
Italy
Research Site
Asahikawa-Shi, 070-8644
Japan
Research Site
Bunkyō City, 113-8431
Japan
Research Site
Bunkyō City, 113-8603
Japan
Research Site
Chiba, 260-0877
Japan
Research Site
Fukuoka, 810-8563
Japan
Research Site
Hiroshima, 734-8551
Japan
Research Site
Iruma-Gun, 350-0495
Japan
Research Site
Kawachinagano-shi, 586-8521
Japan
Research Site
Kawasaki-shi, 216-8511
Japan
Research Site
Nagoya, 457-0866
Japan
Research Site
Nagoya, 467-0001
Japan
Research Site
Okayama, 700-8557
Japan
Research Site
Omura-shi, 856-8562
Japan
Research Site
Sendai, 980-8574
Japan
Research Site
Shinjuku-ku, 160-8582
Japan
Research Site
Tachikawa-shi, 190-0014
Japan
Research Site
Yotsukaido-shi, 284-0003
Japan
Research Site
Culiacán, 80020
Mexico
Research Site
D.F, 14000
Mexico
Research Site
Guadalajara, 44600
Mexico
Research Site
Guadalajara, 44650
Mexico
Research Site
Guadalajara, 44690
Mexico
Research Site
Mexico City, 03310
Mexico
Research Site
Mexico City, 06700
Mexico
Research Site
México, 06090
Mexico
Research Site
México, 11850
Mexico
Research Site
Amsterdam, 1105 AZ
Netherlands
Research Site
Bialystok, 15-276
Poland
Research Site
Krakow, 30-002
Poland
Research Site
Krakow, 30-105
Poland
Research Site
Lodz, 90-549
Poland
Research Site
Poznan, 60-218
Poland
Research Site
Poznan, 61-545
Poland
Research Site
Warsaw, 00-874
Poland
Research Site
Warsaw, 02-637
Poland
Research Site
Wroclaw, 50-556
Poland
Research Site
Caguas, 00725
Puerto Rico
Research Site
San Juan, 00918
Puerto Rico
Research Site
Daejeon, 35015
South Korea
Research Site
Seoul, 02447
South Korea
Research Site
Seoul, 04401
South Korea
Research Site
Seoul, 06591
South Korea
Research Site
Seoul, 133792
South Korea
Research Site
A Coruña, 15006
Spain
Research Site
Barcelona, 08003
Spain
Research Site
Barcelona, 08035
Spain
Research Site
Barcelona, 08041
Spain
Research Site
Córdoba, 14004
Spain
Research Site
L'Hospitalet de Llobregat, 08907
Spain
Research Site
Madrid, 28034
Spain
Research Site
Madrid, 28041
Spain
Research Site
Sabadell, 08208
Spain
Research Site
Valladolid, 47012
Spain
Research Site
Stockholm, 171 76
Sweden
Research Site
Uppsala, 751 85
Sweden
Research Site
Kaohsiung City, 81362
Taiwan
Research Site
Kaohsiung City, 833
Taiwan
Research Site
New Taipei City, 220
Taiwan
Research Site
Taichung, 40447
Taiwan
Research Site
Taichung, 40705
Taiwan
Research Site
Taipei, 112
Taiwan
Research Site
Taoyuan, 333
Taiwan
Research Site
Edinburgh, EH4 2XU
United Kingdom
Research Site
London, NW3 2QG
United Kingdom
Research Site
Wolverhampton, WV10 0QP
United Kingdom
Research Site
Hanoi, 100000
Vietnam
Research Site
Hanoi, 10000
Vietnam
Research Site
Hà Nội, 100000
Vietnam
Research Site
Hà Nội, 100000
Vietnam
Research Site
Ho Chi Minh City, 700000
Vietnam
Research Site
Ho Chi Minh City, 700000
Vietnam
Research Site
Hochiminh City, 700000
Vietnam
Research Site
Hồ Chí Minh, 700000
Vietnam
Research Site
Huế, 530000
Vietnam