Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

December 14, 2020

Primary Completion Date

January 15, 2025

Study Completion Date

August 26, 2026

Conditions
Immune Thrombocytopenia
Interventions
DRUG

Rilzabrutinib

400mg Caplet

DRUG

Placebo

400mg Caplet

Trial Locations (155)

1083

Investigational Site Number : 34803, Budapest

1140

Investigational Site Number : 4002, Vienna

1714

Investigational Site Number : 57801, Grålum

2145

Investigational Site Number : 3608, Westmead

2217

Investigational Site Number : 3607, Kogarah

3199

Investigational Site Number : 3606, Frankston

4032

Investigational Site Number : 34805, Debrecen

4101

Investigational Site Number : 3611, Brisbane

4400

Investigational Site Number : 4003, Steyr

4405

Investigational Site Number : 34804, Nyíregyháza

5000

Investigational Site Number : 3609, Adelaide

5021

Investigational Site Number : 57802, Bergen

5400

Investigational Site Number : 3208, San Juan

6000

Investigational Site Number : 3610, Perth

8000

Investigational Site Number : 34802, Székesfehérvár

8036

Investigational Site Number : 4005, Graz

8700

Investigational Site Number : 4004, Leoben

9024

Investigational Site Number : 34801, Győr

10117

Investigational Site Number : 27610, Berlin

10330

Investigational Site Number : 76405, Bangkok

10400

Investigational Site Number : 76404, Bangkok

10461

Montefiore Medical Center_Investigational Site Number 84032, The Bronx

16499

Investigational Site Number : 41001, Suwon

19104

The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027, Philadelphia

20123

Investigational Site Number : 38015, Milan

20142

Investigational Site Number : 38013, Milan

21079

Investigational Site Number : 25010, Dijon

28007

Investigational Site Number : 72410, Madrid

29010

Investigational Site Number : 72408, Málaga

30008

Investigational Site Number : 72411, Murcia

30322

Children's Healthcare of Atlanta_Investigational Site Number 84034, Atlanta

31200

Investigational Site Number : 48402, Chihuahua City

33600

Investigational Site Number : 25007, Pessac

34000

Investigational Site Number : 48404, Durango

34093

Investigational Site Number 79210, Istanbul

34125

Investigational Site Number : 38010, Trieste

34607

ASCLEPES Research Centers_Investigational Site Number 84023, Weeki Wachee

35100

Investigational Site Number 79206, Izmir

36100

Investigational Site Number : 38011, Vicenza

38039

Investigational Site Number 79209, Kayseri

40002

Investigational Site Number : 76401, Khon Kaen

40138

Investigational Site Number : 38012, Bologna

40202

University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033, Louisville

40497

Investigational Site Number 27612, Düsseldorf

41013

Investigational Site Number : 72413, Seville

44093

Investigational Site Number : 25009, Nantes

44106

University Hospitals Cleveland Medical Center Site Number : 84036, Cleveland

44195

Cleveland Clinic_Investigational Site Number 84026, Cleveland

45030

Investigational Site Number : 48403, Zapopan

45659

Investigational Site Number : 27611, Recklinghausen

46010

Investigational Site Number : 72407, Valencia

49102

Investigational Site Number : 80408, Dnipropetrovsk

49241

Investigational Site Number : 41004, Busan

49933

Investigational Site Number : 25014, Angers

50025

Investigational Site Number : 80409, Kryvyi Rih

50134

Investigational Site Number : 38014, Florence

50200

Investigational Site Number : 76402, Chiang Mai

52621

Investigational Site Number : 37608, Tel Litwinsky

60596

Investigational Site Number : 27613, Frankfurt am Main

60612

Rush University Medical Center_Investigational Site Number 84029, Chicago

63000

Investigational Site Number : 15613, Tangshan

64460

Investigational Site Number : 48401, Monterrey

70300

Investigational Site Number : 37609, Ẕerifin

75012

Investigational Site Number : 25008, Paris

75019

Investigational Site Number : 25012, Paris

80045

Children's Hospital Colorado_Investigational Site Number 84025, Aurora

80112

IMMUNOe International Research Centers_Investigational Site Number 84028, Centennial

84112

University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035, Salt Lake City

90033

University of Southern California_Investigational Site Number 84024, Los Angeles

90110

Investigational Site Number : 76403, Songkhla

90502

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037, Torrance

90602

The Oncology Institute of Hope and Innovation_Investigational Site Number 84031, Whittier

94000

Investigational Site Number : 25011, Créteil

94158

UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020, San Francisco

98195

University of Washington Medical Centre Site Number : 84041, Seattle

110022

Shengjing Hospital of China Medical University - Investigational Site Number: 15603, Shenyang

119049

Investigational Site Number : 64307, Moscow

119228

Investigational Site Number : 70201, Singapore

125167

Investigational Site Number : 64305, Moscow

169608

Investigational Site Number : 70202, Singapore

191024

Investigational Site Number : 64302, Saint Petersburg

212001

Investigational Site Number : 15614, Zhenjiang

214023

Investigational Site Number : 15609, Wuxi

250012

Qilu Hospital of Shandong University - Investigational Site Number: 15605, Jinan

300020

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Investigational Site Number: 15602, Tianjin

300053

Investigational Site Number : 64303, Tula

308433

Investigational Site Number : 70203, Singapore

310018

Investigational Site Number : 15611, Hangzhou

322000

Investigational Site Number : 15202, Viña del Mar

330006

Investigational Site Number : 15610, Nanchang

357502

Investigational Site Number : 64301, Pyatigorsk

430022

Wuhan Union Hospital of Tongji Medical College of HUST - Investigational Site Number: 15601, Wuhan

443099

Investigational Site Number : 64306, Samara

630090

Investigational Site Number : 64304, Novosibirsk

650101

Second Affiliated Hospital of Kunming Medical University - Investigational Site Number: 15604, Kunming

710068

Shaanxi Provincial People's Hospital - Investigational Site Number: 15607, Xi'an

1720430

Investigational Site Number : 15201, La Serena

3109601

Investigational Site Number : 37605, Haifa

4428164

Investigational Site Number : 37606, Kfar Saba

6423906

Investigational Site Number : 37607, Tel Aviv

7500653

Investigational Site Number : 15204, Santiago

20211030

HEMORIO - Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti Site Number : 7609, Rio de Janeiro

41253190

Hospital Sao Rafael Instituto D'Or da Bahia Site Number : 7608, Salvador

02114

Massachusetts General Hospital Site Number : 84038, Boston

C1280AEB

Investigational Site Number : 3206, Capital Federal

B1900

Investigational Site Number : 3211, La Plata

X5003DCE

Investigational Site Number : 3205, Córdoba

W3410 FND

Investigational Site Number : 3209, Corrientes

A4020

Investigational Site Number : 4001, Linz

85806-300

Uniao Oeste Paranaense de Estudos e Combates ao Cancer Site Number : 7610, Cascavel

90035 003

Hospital De Clinicas De Porto Alegre Site Number : 7605, Porto Alegre

08270-070

Hospital Santa Marcelina Site Number : 7611, São Paulo

66053-000

CEMEC Oncologica do Brasil Site Number : 7606, Belém

04039-004

Hospital do Servidor Publico Estadual de Sao Paulo Site Number : 7607, São Paulo

T6G 2P4

Investigational Site Number : 12404, Edmonton

M5G 1X8

Investigational Site Number : 12406, Toronto

H3T 1C5

CHU Sainte-Justine_Investigational site number 12405, Montreal

Unknown

Investigational Site Number : 15608, Hefei

Investigational Site Number : 39214, Tsuchiura-shi

Investigational Site Number : 72416, Burgos

920-8530

Investigational Site Number : 39205, Kanazawa

252-0375

Investigational Site Number : 39207, Sagamihara-shi

565-0871

Investigational Site Number : 39202, Suita-shi

350-0495

Investigational Site Number : 39201, Iruma-gun

113-8655

Investigational Site Number : 39208, Bunkyo-ku

152-8902

Investigational Site Number : 39210, Meguro-ku

157-0074

Investigational Site Number : 39204, Setagaya City

130-8575

Investigational Site Number : 39209, Sumida-ku

60-0852

Investigational Site Number : 39212, Chiba

730-8619

Investigational Site Number : 39203, Hiroshima

330-8777

Investigational Site Number : 39206, Saitama-shi

03720

Investigational Site Number : 48405, Delegacion Benito Juarez

06760

Investigational Site Number : 48406, Mexico City

3015 GD

Erasmus MC_Investigational Site Number 52801, Rotterdam

64-920

Investigational Site Number : 61617, Piła

76-200

Investigational Site Number : 61609, Słupsk

81-519

Investigational Site Number : 61615, Gdynia

61 696

Investigational Site Number : 61614, Poznan

02-776

Investigational Site Number : 61612, Warsaw

50-556

Investigational Site Number : 61613, Wroclaw

02841

Investigational Site Number : 41003, Seoul

03080

Investigational Site Number : 41005, Seoul

03722

Investigational Site Number : 41006, Seoul

08035

Investigational Site Number : 72412, Barcelona

Investigational Site Number : 72414, Barcelona

08041

Investigational Site Number : 72409, Barcelona

06620

Investigational Site Number 79208, Ankara

03143

Investigational Site Number : 80410, Kyiv

W12 0HS

Investigational Site Number : 82607, London

HA1 3UJ

Investigational Site Number : 82604, Harrow

SE5 9PJ

Investigational Site Number : 82606, London

W2 1NY

Investigational Site Number : 82609, London

M13 9WL

Investigational Site Number : 82603, Manchester

NR31 6LA

Investigational Site Number : 82605, Norfolk

SO16 6YD

Investigational Site Number : 82608, Southampton

All Listed Sponsors
lead

Principia Biopharma, a Sanofi Company

INDUSTRY