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)

PHASE3RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 20, 2024

Primary Completion Date

May 14, 2027

Study Completion Date

August 4, 2028

Conditions
Polymyositis, Dermatomyositis
Interventions
COMBINATION_PRODUCT

Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

OTHER

Placebo

Matched placebo delivered subcutaneously, once weekly for 52 weeks

COMBINATION_PRODUCT

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

Trial Locations (217)

112

RECRUITING

Research Site, Taipei

220

RECRUITING

Research Site, New Taipei City

333

WITHDRAWN

Research Site, Taoyuan District

833

RECRUITING

Research Site, Kaohsiung City

1090

NOT_YET_RECRUITING

Research Site, Vienna

1680

RECRUITING

Research Site, Sofia

2050

RECRUITING

Research Site, Camperdown

2100

WITHDRAWN

Research Site, Copenhagen

2310

WITHDRAWN

Research Site, New Lambton

3000

RECRUITING

Research Site, Leuven

4001

RECRUITING

Research Site, Plovdiv

4002

RECRUITING

Research Site, Plovdiv

4032

RECRUITING

Research Site, Debrecen

4222

RECRUITING

Research Site, Southport

5000

NOT_YET_RECRUITING

Research Site, Odense C

5011

RECRUITING

Research Site, Woodville South

6003

WITHDRAWN

Research Site, Stara Zagora

6009

RECRUITING

Research Site, Nedlands

6304

RECRUITING

Research Site, Haskovo

6725

RECRUITING

Research Site, Szeged

8036

RECRUITING

Research Site, Graz

8200

RECRUITING

Research Site, Aarhus N

9000

RECRUITING

Research Site, Ghent

10000

NOT_YET_RECRUITING

Research Site, Hanoi

10117

RECRUITING

Research Site, Berlin

11021

NOT_YET_RECRUITING

Research Site, Great Neck

11850

RECRUITING

Research Site, México

12850

RECRUITING

Research Site, Prague

14000

WITHDRAWN

Research Site, D.F

14004

RECRUITING

Research Site, Córdoba

15006

RECRUITING

Research Site, A Coruña

15213

NOT_YET_RECRUITING

Research Site, Pittsburgh

18101

RECRUITING

Research Site, Afula

20037

RECRUITING

Research Site, Washington D.C.

20089

NOT_YET_RECRUITING

Research Site, Rozzano

20132

RECRUITING

Research Site, Milan

20161

WITHDRAWN

Research Site, Milan

21224

NOT_YET_RECRUITING

Research Site, Baltimore

27100

RECRUITING

Research Site, Pavia

27710

NOT_YET_RECRUITING

Research Site, Durham

28034

RECRUITING

Research Site, Madrid

28041

RECRUITING

Research Site, Madrid

28207

WITHDRAWN

Research Site, Charlotte

28211

NOT_YET_RECRUITING

Research Site, Charlotte

29425

NOT_YET_RECRUITING

Research Site, Charleston

29486

RECRUITING

Research Site, Summerville

29609

RECRUITING

Research Site, Brest

30322

RECRUITING

Research Site, Atlanta

31059

RECRUITING

Research Site, Toulouse

32603

WITHDRAWN

Research Site, Gainesville

32819

RECRUITING

Research Site, Orlando

33063

RECRUITING

Research Site, Margate

33126

WITHDRAWN

Research Site, Miami

33410

RECRUITING

Research Site, Palm Beach Gardens

33472

WITHDRAWN

Research Site, Boynton Beach

33486

RECRUITING

Research Site, Boca Raton

33563

NOT_YET_RECRUITING

Research Site, Plant City

34362

RECRUITING

Research Site, Haifa

35015

RECRUITING

Research Site, Daejeon

35128

RECRUITING

Research Site, Padua

40447

RECRUITING

Research Site, Taichung

44130

WITHDRAWN

Research Site, Middleburg Heights

44195

RECRUITING

Research Site, Cleveland

44600

RECRUITING

Research Site, Guadalajara

44649

NOT_YET_RECRUITING

Research Site, Herne

44650

NOT_YET_RECRUITING

Research Site, Guadalajara

44690

NOT_YET_RECRUITING

Research Site, Guadalajara

47012

RECRUITING

Research Site, Valladolid

48109

RECRUITING

Research Site, Ann Arbor

49033

RECRUITING

Research Site, Angers

51100

RECRUITING

Research Site, Reims

52621

RECRUITING

Research Site, Ramat Gan

53100

NOT_YET_RECRUITING

Research Site, Siena

53127

RECRUITING

Research Site, Bonn

53226

RECRUITING

Research Site, Milwaukee

56126

NOT_YET_RECRUITING

Research Site, Pisa

59037

RECRUITING

Research Site, Lille

60126

RECRUITING

Research Site, Ancona

60527

NOT_YET_RECRUITING

Research Site, Willowbrook

61231

WITHDRAWN

Research Site, Bad Nauheim

66205

RECRUITING

Research Site, Fairway

67098

RECRUITING

Research Site, Strasbourg

69437

NOT_YET_RECRUITING

Research Site, Lyon

70124

RECRUITING

Research Site, Bari

72037

RECRUITING

Research Site, Le Mans

72076

RECRUITING

Research Site, Tübingen

75010

NOT_YET_RECRUITING

Research Site, Paris

75013

RECRUITING

Research Site, Allen

75651

RECRUITING

Research Site, Paris

76000

RECRUITING

Research Site, Rouen

76034

NOT_YET_RECRUITING

Research Site, Colleyville

76180

RECRUITING

Research Site, North Richland Hills

79106

RECRUITING

Research Site, Freiburg im Breisgau

79902

RECRUITING

Research Site, El Paso

80020

RECRUITING

Research Site, Culiacán

80045

RECRUITING

Research Site, Aurora

80230

WITHDRAWN

Research Site, Denver

80336

RECRUITING

Research Site, München

81362

RECRUITING

Research Site, Kaohsiung City

90127

RECRUITING

Research Site, Palermo

91120

RECRUITING

Research Site, Jerusalem

92617

RECRUITING

Research Site, Irvine

95100

RECRUITING

Research Site, Catania

100000

RECRUITING

Research Site, Hanoi

RECRUITING

Research Site, Hà Nội

WITHDRAWN

Research Site, Hà Nội

100029

RECRUITING

Research Site, Beijing

100044

WITHDRAWN

Research Site, Beijing

100191

RECRUITING

Research Site, Beijing

110060

WITHDRAWN

Research Site, New Delhi

122001

WITHDRAWN

Research Site, Gurugram

133792

RECRUITING

Research Site, Seoul

200025

RECRUITING

Research Site, Osorno

RECRUITING

Research Site, Shanghai

200032

RECRUITING

Research Site, Shanghai

200040

RECRUITING

Research Site, Shanghai

210029

RECRUITING

Research Site, Nanjing

226030

NOT_YET_RECRUITING

Research Site, Lucknow

248016

WITHDRAWN

Research Site, Dehradun

272011

RECRUITING

Research Site, Jining

310014

RECRUITING

Research Site, Hangzhou

325000

RECRUITING

Research Site, Wenzhou

380006

WITHDRAWN

Research Site, Ahmedabad

382421

WITHDRAWN

Research Site, Ahmedabad

400012

WITHDRAWN

Research Site, Mumbai

400053

RECRUITING

Research Site, Mumbai

402260

RECRUITING

Research Site, Chongqing

421001

RECRUITING

Research Site, Hengyang

450052

RECRUITING

Research Site, Zhengzhou

500003

RECRUITING

Research Site, Secunderabad

500082

RECRUITING

Research Site, Hyderabad

510317

RECRUITING

Research Site, Guangzhou

510630

RECRUITING

Research Site, Guangzhou

523009

RECRUITING

Research Site, Dongguan

530000

RECRUITING

Research Site, Huế

570004

RECRUITING

Research Site, Mysuru

605006

WITHDRAWN

Research Site, Puducherry

700000

RECRUITING

Research Site, Ho Chi Minh City

WITHDRAWN

Research Site, Hochiminh City

RECRUITING

Research Site, Hồ Chí Minh

700020

RECRUITING

Research Site, Kolkata

4070022

RECRUITING

Research Site, Concepción

4428164

RECRUITING

Research Site, Kfar Saba

7560908

RECRUITING

Research Site, Las Condes

7691236

RECRUITING

Research Site, Santiago

8330034

RECRUITING

Research Site, Santiago

8420383

WITHDRAWN

Research Site, Santiago

06519

RECRUITING

Research Site, New Haven

02115

NOT_YET_RECRUITING

Research Site, Boston

C1180AAX

NOT_YET_RECRUITING

Research Site, Buenos Aires

C1405BCH

NOT_YET_RECRUITING

Research Site, Buenos Aires

C1431FWO

RECRUITING

Research Site, CABA

B1878GEG

NOT_YET_RECRUITING

Research Site, Quilmes

T4000AXL

NOT_YET_RECRUITING

Research Site, San Miguel de Tucumán

B-2170

WITHDRAWN

Research Site, Merksem

89202-190

RECRUITING

Research Site, Joinville

36010 570

RECRUITING

Research Site, Juiz de Fora

96040-010

WITHDRAWN

Research Site, Pelotas

90620-110

RECRUITING

Research Site, Porto Alegre

40150-150

RECRUITING

Research Site, Salvador

41253-190

RECRUITING

Research Site, Salvador

15090-000

RECRUITING

Research Site, São José do Rio Preto

01233-907

RECRUITING

Research Site, São Paulo

T2N 4L7

NOT_YET_RECRUITING

Research Site, Calgary

T3M1M4

SUSPENDED

Research Site, Calgary

H3T 1E2

RECRUITING

Research Site, Montreal

CN-100730

RECRUITING

Research Site, Beijing

Unknown

RECRUITING

Research Site, Shanghai

RECRUITING

Research Site, Taichung

050001

RECRUITING

Research Site, Shijiazhuang

400 078

RECRUITING

Research Site, Mumbai

00128

RECRUITING

Research Site, Roma

00161

RECRUITING

Research Site, Roma

00189

RECRUITING

Research Site, Roma

070-8644

RECRUITING

Research Site, Asahikawa-shi

113-8603

RECRUITING

Research Site, Bunkyō City

260-0877

WITHDRAWN

Research Site, Chiba

810-8563

RECRUITING

Research Site, Fukuoka

350-0495

RECRUITING

Research Site, Iruma-Gun

586-8521

RECRUITING

Research Site, Kawachinagano-shi

216-8511

RECRUITING

Research Site, Kawasaki-shi

457-0866

RECRUITING

Research Site, Nagoya

467-0001

RECRUITING

Research Site, Nagoya

700-8557

RECRUITING

Research Site, Okayama

856-8562

RECRUITING

Research Site, Omura-shi

980-8574

NOT_YET_RECRUITING

Research Site, Sendai

160-8582

RECRUITING

Research Site, Shinjuku-ku

190-0014

RECRUITING

Research Site, Tachikawa-shi

284-0003

RECRUITING

Research Site, Yotsukaido-shi

03310

RECRUITING

Research Site, Mexico City

06700

RECRUITING

Research Site, Mexico City

06090

WITHDRAWN

Research Site, México

1105 AZ

RECRUITING

Research Site, Amsterdam

15-276

WITHDRAWN

Research Site, Bialystok

30-002

RECRUITING

Research Site, Krakow

30-721

RECRUITING

Research Site, Krakow

90-549

RECRUITING

Research Site, Lodz

60-218

RECRUITING

Research Site, Poznan

61-545

RECRUITING

Research Site, Poznan

00-874

RECRUITING

Research Site, Warsaw

02-637

RECRUITING

Research Site, Warsaw

50-556

RECRUITING

Research Site, Wroclaw

00725

NOT_YET_RECRUITING

Research Site, Caguas

00918

RECRUITING

Research Site, San Juan

02447

RECRUITING

Research Site, Seoul

04401

RECRUITING

Research Site, Seoul

06591

RECRUITING

Research Site, Seoul

08003

RECRUITING

Research Site, Barcelona

08035

RECRUITING

Research Site, Barcelona

08041

NOT_YET_RECRUITING

Research Site, Barcelona

08907

RECRUITING

Research Site, L'Hospitalet de Llobregat

08208

RECRUITING

Research Site, Sabadell

171 76

WITHDRAWN

Research Site, Stockholm

751 85

NOT_YET_RECRUITING

Research Site, Uppsala

EH4 2XU

RECRUITING

Research Site, Edinburgh

NW3 2QG

RECRUITING

Research Site, London

WV10 0QP

RECRUITING

Research Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY