Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

March 6, 2023

Primary Completion Date

April 24, 2026

Study Completion Date

December 18, 2028

Conditions
Primary Immune Thrombocytopenia (ITP)
Interventions
BIOLOGICAL

Ianalumab

Intravenous infusion, prepared from concentrate solution

DRUG

Placebo

Intravenous infusion, prepared from matching placebo

DRUG

Corticosteroids

Oral or parental (if clinically justified)

Trial Locations (124)

1140

Novartis Investigative Site, Vienna

1280

Novartis Investigative Site, Caba

1431

Novartis Investigative Site, Sofia

1714

Novartis Investigative Site, Grålum

2605

Novartis Investigative Site, Garran

2930

Novartis Investigative Site, Brasschaat

3000

Novartis Investigative Site, Leuven

3004

Novartis Investigative Site, Melbourne

3168

Novartis Investigative Site, Clayton

4000

Novartis Investigative Site, San Miguel de Tucumán

4002

Novartis Investigative Site, Plovdiv

4032

Novartis Investigative Site, Debrecen

4102

Novartis Investigative Site, Wooloongabba

5000

Novartis Investigative Site, Córdoba

5020

Novartis Investigative Site, Salzburg

6020

Novartis Investigative Site, Innsbruck

8000

Novartis Investigative Site, Bruges

8800

Novartis Investigative Site, Roeselare

10050

Novartis Investigative Site, George Town

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

10960

Hematology Oncology Association of Rockland, Nyack

11042

Clinical Research Alliance, Lake Success

14033

Novartis Investigative Site, Caen

14080

Novartis Investigative Site, Mexico City

20817

Oncology Care Associates, Bethesda

28009

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

30008

Novartis Investigative Site, Murcia

33063

Napa Research, Margate

34098

Novartis Investigative Site, Istanbul

34129

Novartis Investigative Site, Trieste

35000

Novartis Investigative Site, Rennes

35392

Novartis Investigative Site, Giessen

36100

Novartis Investigative Site, Vicenza

37007

Novartis Investigative Site, Salamanca

40138

Novartis Investigative Site, Bologna

41013

Novartis Investigative Site, Seville

44195

Cleveland Clinic Foundation, Cleveland

45147

Novartis Investigative Site, Essen

45402

STAT Research Inc, Dayton

46845

Parkview Research Center, Fort Wayne

48334

Michigan Center of Medical Research, Farmington Hills

50134

Novartis Investigative Site, Florence

50200

Novartis Investigative Site, Chiang Mai

55200

Novartis Investigative Site, Samsun

55416

Metro Minnesota CCOP, Saint Louis Park

55905

Mayo Clinic Rochester, Rochester

58260

Novartis Investigative Site, Morelia

59037

Novartis Investigative Site, Lille

59102

St Vincent Frontier Cancer Center, Billings

60590

Novartis Investigative Site, Frankfurt am Main

60637

Uni of Chi Medi Ctr Hema and Onco, Chicago

64460

Novartis Investigative Site, Monterrey

68000

Novartis Investigative Site, Kuala Selangor

72000

Novartis Investigative Site, Le Mans

73000

Novartis Investigative Site, Chambéry

78229

Mays Cancer Ctr Uthsa Mdacc, San Antonio

80045

University of Colorado Anschutz, Aurora

80100

Novartis Investigative Site, Johor Bahru

84405

Community Cancer Trials of Utah, Ogden

85349

Yuma Regional Medical Center, Yuma

92708

Compassionate Care Res Group Inc, Fountain Valley

93586

Novartis Investigative Site, Kuching

93611

Community Cancer Institute, Clovis

100000

Novartis Investigative Site, Hanoi

100044

Novartis Investigative Site, Beijing

116000

Novartis Investigative Site, Dalian

119074

Novartis Investigative Site, Singapore

169608

Novartis Investigative Site, Singapore

213004

Novartis Investigative Site, Changzhou

233004

Novartis Investigative Site, Bengbu

249203

Novartis Investigative Site, Rishikesh

300020

Novartis Investigative Site, Tianjin

310006

Novartis Investigative Site, Hangzhou

330006

Novartis Investigative Site, Nanchang

380013

Novartis Investigative Site, Ahmedabad

400012

Novartis Investigative Site, Mumbai

430022

Novartis Investigative Site, Wuhan

450052

Novartis Investigative Site, Zhengzhou

471003

Novartis Investigative Site, Luoyang

510515

Novartis Investigative Site, Guangzhou

518037

Novartis Investigative Site, Shenzhen

610041

Novartis Investigative Site, Chengdu

650101

Novartis Investigative Site, Kunming

700094

Novartis Investigative Site, Kolkata

710004

Novartis Investigative Site, Xi'an

738000

Novartis Investigative Site, Ho Chi Minh City

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Med Center, Boston

02903

Rhode Island Hospital, Providence

C1414DRK

Novartis Investigative Site, CABA

C1039AAC

Novartis Investigative Site, Buenos Aires

C1015ABO

Novartis Investigative Site, Caba

050000

Novartis Investigative Site, Shijiazhuang

708 52

Novartis Investigative Site, Ostrava

625 00

Novartis Investigative Site, Brno

100 34

Novartis Investigative Site, Prague

128 08

Novartis Investigative Site, Prague

01307

Novartis Investigative Site, Dresden

Novartis Investigative Site, Dresden

07740

Novartis Investigative Site, Jena

000000

Novartis Investigative Site, New Territories

Unknown

Novartis Investigative Site, Hong Kong

H-1083

Novartis Investigative Site, Budapest

00168

Novartis Investigative Site, Roma

480-1195

Novartis Investigative Site, Nagakute

377-0280

Novartis Investigative Site, Shibukawa

060-8604

Novartis Investigative Site, Sapporo

701-1192

Novartis Investigative Site, Okayama

350-0495

Novartis Investigative Site, Iruma-gun

260-0852

Novartis Investigative Site, Chiba

815-8555

Novartis Investigative Site, Fukuoka

500 8513

Novartis Investigative Site, Gifu

543-8555

Novartis Investigative Site, Osaka

06726

Novartis Investigative Site, Mexico City

013975

Novartis Investigative Site, Bucharest

030171

Novartis Investigative Site, Bucharest

S308433

Novartis Investigative Site, Singapore

08035

Novartis Investigative Site, Barcelona

09100

Novartis Investigative Site, Aydin

B15 2TH

Novartis Investigative Site, Birmingham

W12 0HS

Novartis Investigative Site, London

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY