Phase
Condition
Idiopathic Inflammatory Myopathies
Lupus
Collagen Vascular Diseases
Treatment
Anifrolumab (unblinded, open label)
Placebo
Anifrolumab (blinded)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Capable of giving informed consent.
Inclusion Criteria:
18 - 75 years old
Body weight 40 kg - ≤ 100 kg
Must have "probable" or "definite" diagnosis of PM or DM according to the 2017ACR/EULAR classification criteria for adult myositis.
Moderate or severe disease activity per core set measurements.
Currently receiving oral prednisone or other polymyositis or dermatomyositistreatments at a stable dose.
No history of active tuberculosis or severe COVID-19.
Male and female participants must follow contraception guidelines.
Exclusion
Exclusion Criteria:
Participants with documented inclusion body myositis (IBM), immune mediationnecrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years priorto signing the ICF), drug-induced myositis, cancer associated myositis, amyopathicDM, and non inflammatory myopathies (eg, muscular dystrophies).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
Participants with severe muscle damage or permanent weakness due to non-PM or non-DMconditions (i.e. stroke) as per the investigator's opinion.
Any history of severe case of herpes zoster infection
History of cancer (except adequately treated basal cell carcinoma or cervical cancerin-situ), immunodeficiency, HIV, HBV, active HCV .
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completelyresolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatmentwithin 3 years prior to randomization.
Recent non-opportunistic infection requiring hospitalization or anti-infectivetreatment.
Recent or concurrent enrollment in another clinical study with an investigationalproduct.
Lactating, breastfeeding, or pregnant females or females who intend to becomepregnant or begin breastfeeding
Study Design
Connect with a study center
Research Site
Camperdown, 2050
AustraliaActive - Recruiting
Research Site
Nedlands, 6009
AustraliaActive - Recruiting
Research Site
New Lambton, 2310
AustraliaSite Not Available
Research Site
Woodville South, 5011
AustraliaActive - Recruiting
Research Site
Graz, 8036
AustriaActive - Recruiting
Research Site
Gent, 9000
BelgiumSite Not Available
Research Site
Leuven, 3000
BelgiumSite Not Available
Research Site
Merksem, B-2170
BelgiumSite Not Available
Research Site
Joinville, 89202-190
BrazilActive - Recruiting
Research Site
Juiz de Fora, 36010 570
BrazilActive - Recruiting
Research Site
Pelotas, 96040-010
BrazilSite Not Available
Research Site
Porto Alegre, 90620-110
BrazilActive - Recruiting
Research Site
Salvador, 40150-150
BrazilSite Not Available
Research Site
Sao Jose Do Rio Preto, 15090-000
BrazilActive - Recruiting
Research Site
Sao Paulo, 01233-907
BrazilSite Not Available
Research Site
Haskovo, 6304
BulgariaActive - Recruiting
Research Site
Plovdiv, 4002
BulgariaSite Not Available
Research Site
Sofia, 1680
BulgariaSite Not Available
Research Site
Stara Zagora, 6003
BulgariaSite Not Available
Research Site
Calgary, Alberta T3M1M4
CanadaSite Not Available
Research Site
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Research Site
Concepcion, 4070022
ChileSite Not Available
Research Site
Osorno, 200025
ChileSite Not Available
Research Site
Santiago, 8330044
ChileSite Not Available
Research Site
Beijing, 100191
ChinaActive - Recruiting
Research Site
Chongqing, 402260
ChinaActive - Recruiting
Research Site
Dongguan, 523009
ChinaActive - Recruiting
Research Site
Guangzhou, 510317
ChinaActive - Recruiting
Research Site
Hangzhou, 310014
ChinaActive - Recruiting
Research Site
Hengyang, 421001
ChinaActive - Recruiting
Research Site
Jining, 272011
ChinaActive - Recruiting
Research Site
Nanjing, 210029
ChinaActive - Recruiting
Research Site
Shanghai, 200025
ChinaActive - Recruiting
Research Site
Wenzhou, 325000
ChinaActive - Recruiting
Research Site
Zhengzhou, 450052
ChinaActive - Recruiting
Research Site
Praha 2, 12850
CzechiaSite Not Available
Research Site
Aarhus N, 8200
DenmarkSite Not Available
Research Site
Copenhagen, 2100
DenmarkSite Not Available
Research Site
Odense C, 5000
DenmarkSite Not Available
Research Site
Angers, 49033
FranceSite Not Available
Research Site
Brest Cedex 2, 29609
FranceSite Not Available
Research Site
Le Mans Cedex, 72037
FranceSite Not Available
Research Site
Lille Cedex, 59037
FranceSite Not Available
Research Site
Lyon, 69437
FranceSite Not Available
Research Site
Paris, 75010
FranceSite Not Available
Research Site
Paris Cedex 13, 75651
FranceSite Not Available
Research Site
Reims, 51100
FranceSite Not Available
Research Site
Rouen, 76000
FranceSite Not Available
Research Site
Strasbourg, 67098
FranceSite Not Available
Research Site
Strasbourg Cedex, 67098
FranceSite Not Available
Research Site
Toulouse, 31059
FranceSite Not Available
Research Site
Bad Nauheim, 61231
GermanySite Not Available
Research Site
Berlin, 10117
GermanySite Not Available
Research Site
Freiburg, 79106
GermanySite Not Available
Research Site
Herne, 44649
GermanySite Not Available
Research Site
München, 80336
GermanySite Not Available
Research Site
Tübingen, 72076
GermanyActive - Recruiting
Research Site
Debrecen, 4032
HungaryActive - Recruiting
Research Site
Szeged, 6725
HungarySite Not Available
Research Site
Ahmedabad, 380006
IndiaSite Not Available
Research Site
Dehradun, 248016
IndiaSite Not Available
Research Site
Gurugram, 122001
IndiaSite Not Available
Research Site
Hyderabad, 500082
IndiaSite Not Available
Research Site
Kolkata, 700020
IndiaActive - Recruiting
Research Site
Mumbai, 400 078
IndiaActive - Recruiting
Research Site
Mysuru, 570004
IndiaActive - Recruiting
Research Site
New Delhi, 110060
IndiaSite Not Available
Research Site
Puducherry, 605006
IndiaSite Not Available
Research Site
Secunderabad, 500003
IndiaSite Not Available
Research Site
Afula, 18101
IsraelActive - Recruiting
Research Site
Haifa, 34362
IsraelActive - Recruiting
Research Site
Jerusalem, 91120
IsraelActive - Recruiting
Research Site
Kfar Saba, 4428164
IsraelActive - Recruiting
Research Site
Ramat Gan, 52621
IsraelActive - Recruiting
Research Site
Ancona, 60126
ItalyActive - Recruiting
Research Site
Bari, 70124
ItalySite Not Available
Research Site
Catania, 95100
ItalyActive - Recruiting
Research Site
Milan, 20132
ItalyActive - Recruiting
Research Site
Milano, 20161
ItalySite Not Available
Research Site
Padova, 35128
ItalySite Not Available
Research Site
Palermo, 90127
ItalySite Not Available
Research Site
Pavia, 27100
ItalySite Not Available
Research Site
Pisa, 56126
ItalySite Not Available
Research Site
Roma, 00161
ItalyActive - Recruiting
Research Site
Asahikawa-shi, 070-8644
JapanActive - Recruiting
Research Site
Bunkyo-ku, 113-8603
JapanActive - Recruiting
Research Site
Chiba-shi, 260-0877
JapanSite Not Available
Research Site
Fukuoka-shi, 810-8563
JapanActive - Recruiting
Research Site
Iruma-Gun, 350-0495
JapanActive - Recruiting
Research Site
Kawachinagano-shi, 586-8521
JapanActive - Recruiting
Research Site
Kawasaki-shi, 216-8511
JapanSite Not Available
Research Site
Nagoya-shi, 457-0866
JapanActive - Recruiting
Research Site
Omura-shi, 856-8562
JapanActive - Recruiting
Research Site
Sendai-shi, 980-8574
JapanSite Not Available
Research Site
Shinjuku-ku, 160-8582
JapanActive - Recruiting
Research Site
Tachikawa-shi, 190-0014
JapanActive - Recruiting
Research Site
Yotsukaido-shi, 284-0003
JapanSite Not Available
Research Site
Daejeon, 35015
Korea, Republic ofSite Not Available
Research Site
Seoul, 02447
Korea, Republic ofSite Not Available
Research Site
Ciudad de Mexico, 06700
MexicoActive - Recruiting
Research Site
Culiacan, 80020
MexicoSite Not Available
Research Site
D.F, 14000
MexicoSite Not Available
Research Site
Guadalajara, 44690
MexicoSite Not Available
Research Site
Mexico, 11850
MexicoActive - Recruiting
Research Site
Mexico City, 03310
MexicoActive - Recruiting
Research Site
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Research Site
Białystok, 15-276
PolandSite Not Available
Research Site
Kraków, 30-721
PolandActive - Recruiting
Research Site
Poznań, 61-545
PolandActive - Recruiting
Research Site
Warszawa, 02-637
PolandSite Not Available
Research Site
Wrocław, 50-556
PolandSite Not Available
Research Site
Łódź, 90-549
PolandActive - Recruiting
Research Site
Barcelona, 08035
SpainActive - Recruiting
Research Site
Cordoba, 14004
SpainActive - Recruiting
Research Site
Hospitalet de Llobregat, 08907
SpainSite Not Available
Research Site
L'Hospitalet de Llobregat, 08907
SpainSite Not Available
Research Site
La Coruña, 15006
SpainActive - Recruiting
Research Site
Madrid, 28041
SpainActive - Recruiting
Research Site
Sabadell, 08208
SpainActive - Recruiting
Research Site
Valladolid, 47012
SpainSite Not Available
Research Site
Stockholm, 171 76
SwedenSite Not Available
Research Site
Uppsala, 751 85
SwedenSite Not Available
Research Site
Kaohsiung, 833
TaiwanActive - Recruiting
Research Site
New Taipei, 220
TaiwanActive - Recruiting
Research Site
Taichung, 40447
TaiwanActive - Recruiting
Research Site
Taipei, 112
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Edinburgh, EH4 2XU
United KingdomActive - Recruiting
Research Site
London, NW3 2QG
United KingdomActive - Recruiting
Research Site
Wolverhampton, WV10 0QP
United KingdomActive - Recruiting
Research Site
Irvine, California 92617
United StatesSite Not Available
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
Denver, Colorado 80230
United StatesSite Not Available
Research Site
New Haven, Connecticut 06519
United StatesSite Not Available
Research Site
Washington, District of Columbia 20037
United StatesSite Not Available
Research Site
Boca Raton, Florida 33486
United StatesActive - Recruiting
Research Site
Boynton Beach, Florida 33472
United StatesSite Not Available
Research Site
Gainesville, Florida 32608
United StatesSite Not Available
Research Site
Miami, Florida 33126
United StatesSite Not Available
Research Site
Orlando, Florida 32819
United StatesSite Not Available
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Fairway, Kansas 66205
United StatesSite Not Available
Research Site
Ann Arbor, Michigan 48109
United StatesSite Not Available
Research Site
Cleveland, Ohio 44195
United StatesSite Not Available
Research Site
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Research Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Research Site
Allen, Texas 75013
United StatesActive - Recruiting
Research Site
North Richland Hills, Texas 76180
United StatesActive - Recruiting
Research Site
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Research Site
Ha Noi, 100000
VietnamSite Not Available
Research Site
Hanoi, 100000
VietnamSite Not Available
Research Site
Ho Chi Minh, 700000
VietnamSite Not Available
Research Site
Ho Chi Minh city, 700000
VietnamSite Not Available
Research Site
Hochiminh city, 700000
VietnamSite Not Available
Research Site
Hue, 530000
VietnamSite Not Available
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