Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

June 8, 2021

Primary Completion Date

August 22, 2025

Study Completion Date

November 18, 2026

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Medi-546

Patients will have IP administered or will self-administer IP under supervision by site staff at Week 0 and Week 1 and, for patients participating in the OLE period, at Week 52. For weekly doses coinciding with subsequent on-site visits, patients will also have IP administered or will self-administer IP under supervision by site staff, and in addition will receive a set of kits (including back-up kits) for at-home administration.

DRUG

Placebo

Solution for injection in aPFS

Trial Locations (140)

1027

Research Site, Budapest

1097

Research Site, Budapest

1118

Research Site, Quezon City

1407

Research Site, Sofia

1431

Research Site, Sofia

1606

Research Site, Sofia

1643

Research Site, San Isidro

1784

Research Site, Sofia

1797

Research Site, Sofia

1900

Research Site, La Plata

4000

Research Site, San Miguel de Tucumán

4003

Research Site, Plovdiv

5400

Research Site, San Juan

Research Site, Sevlievo

5500

Research Site, Mendoza

5700

Research Site, Gyula

5800

Research Site, Pleven

6600

Research Site, Kardzhali

8000

Research Site, Székesfehérvár

8003

Research Site, Barcelona

8035

Research Site, Barcelona

8200

Research Site, Veszprém

10032

Research Site, New York

10117

Research Site, Berlin

10400

Research Site, Rachathewi

11030

Research Site, Manhasset

11201

Research Site, Brooklyn

13676

Research Site, Potsdam

15224

Research Site, Pittsburgh

15706

Research Site, Santiago de Compostela

19610

Research Site, Reading

21001

Research Site, Vinnytsia

21029

Research Site, Vinnytsia

21200

Research Site, Mexicali

28203

Research Site, Charlotte

28204

Research Site, Charlotte

28702

Research Site, Madrid

31000

Research Site, Chihuahua City

33180

Research Site, Miami

33511

Research Site, Brandon

33613

Research Site, Tampa

33614

Research Site, Tampa

33759

Research Site, Clearwater

33765

Research Site, Clearwater

35233

Research Site, Birmingham

38119

Research Site, Memphis

41010

Research Site, Seville

43080

Research Site, Durango

44130

Research Site, Guadalajara

44650

Research Site, Guadalajara

44950

Research Site, Guadalajara

46026

Research Site, Valencia

48504

Research Site, Flint

48911

Research Site, Lansing

50200

Research Site, Muang

50937

Research Site, Cologne

65025

Research Site, Odesa

69600

Research Site, Zaporizhzhia

72076

Research Site, Tübingen

73104

Research Site, Oklahoma City

76051

Research Site, Grapevine

80000

Research Site, Culiacán

80045

Research Site, Aurora

83404

Research Site, Idaho Falls

85032

Research Site, Phoenix

85253

Research Site, Paradise Valley

88011

Research Site, Las Cruces

90095

Research Site, Los Angeles

91786

Research Site, Upland

91942

Research Site, La Mesa

92020

Research Site, El Cajon

92543

Research Site, Hemet

92586

Research Site, Menifee

92835

Research Site, Fullerton

97000

Research Site, Mérida

97070

Research Site, Mérida

110221

Research Site, Bogotá

230002

Research Site, Montería

250001

Research Site, Chía

680003

Research Site, Bucaramanga

5090000

Research Site, Valdivia

5290000

Research Site, Osorno

7500010

Research Site, Santiago

7500571

Research Site, Santiago

7500588

Research Site, Santiago

7500710

Research Site, Santiago

7501126

Research Site, Santiago

8320000

Research Site, Santiago

07103

Research Site, Newark

C1431FWO

Research Site, Ciudad de Buenos Aires

B2700CPM

Research Site, Pergamino

B1878GEG

Research Site, Quilmes

S2000PBJ

Research Site, Rosario

A4400ANW

Research Site, Salta

T4000AXL

Research Site, San Miguel de Tucumán

T4000ICL

Research Site, San Miguel de Tucumán

080002

Research Site, Barranquilla

080020

Research Site, Barranquilla

04103

Research Site, Leipzig

260-8712

Research Site, Chiba

104-8560

Research Site, Chūōku

431-3192

Research Site, Hamamatsu

734-8551

Research Site, Hiroshima

173-8610

Research Site, Itabashi-ku

761-0793

Research Site, Kita-gun

807-8555

Research Site, Kitakyushu-shi

152-8902

Research Site, Meguro-ku

153-8515

Research Site, Meguro-ku

852-8501

Research Site, Nagasaki

457-8510

Research Site, Nagoya

460-0001

Research Site, Nagoya

700-8607

Research Site, Okayama

252-0375

Research Site, Sagamihara-shi

857-1195

Research Site, Sasebo-shi

980-8574

Research Site, Sendai

160-8582

Research Site, Shinjuku-ku

03100

Research Site, México

03720

Research Site, México

06700

Research Site, México

40-081

Research Site, Katowice

64-000

Research Site, Kościan

30-033

Research Site, Krakow

30-363

Research Site, Krakow

30-510

Research Site, Krakow

90-368

Research Site, Lodz

20-607

Research Site, Lublin

67-100

Research Site, Nowa Sól

43-450

Research Site, Ustroń

00-874

Research Site, Warsaw

02-118

Research Site, Warsaw

02-691

Research Site, Warsaw

50-088

Research Site, Wroclaw

50-244

Research Site, Wroclaw

08036

Research Site, Barcelona

01601

Research Site, Kyiv

02091

Research Site, Kyiv

04050

Research Site, Kyiv

DN2 5LT

Research Site, Doncaster

LS7 4SA

Research Site, Leeds

SE1 9RT

Research Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

AstraZeneca

INDUSTRY