A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

October 8, 2020

Primary Completion Date

November 16, 2022

Study Completion Date

September 30, 2027

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
DRUG

Crovalimab

"Dosing depends on body weight. Participants will be dosed as follows:~* 5 kg to \< 12 kg: 100 mg IV on Week 1 Day 1 (W1D1); 85 mg SC on Week 1 Day 2 (W1D2) and Q2W from Week 3 until end of study~* 12 kg to \< 20 kg: 200 mg IV on W1D1; 85 mg SC on W1D2, Weeks 2, 3 and 4; 170 mg SC, Q2W from Week 5 until end of study~* 20 kg to \< 30 kg: 300 mg IV on W1D1; 85 mg SC on W1D2, Weeks 2, 3 and 4; 340 mg SC, Q4W from Week 5 until end of study~* 30 kg to \< 40 kg: 400 mg IV on W1D1; 170 mg SC on W1D2, Weeks 2, 3 and 4; 510 mg SC, Q4W from Week 5 until end of study~* 40 kg to \< 100 kg: 1000 mg IV on W1D1; 340 mg SC W1D2, Weeks 2, 3 and 4; 680 mg SC, Q4W from Week 5 until end of study~* 100 kg: 1500 mg IV on W1D1; 340 mg SC W1D2, Weeks 2, 3 and 4; 1020 mg SC, Q4W from Week 5 until end of study."

DRUG

Eculizumab

Eculizumab will be administered as specified in the respective arm.

Trial Locations (56)

100

National Taiwan Universtiy Hospital, Taipei

1000

Philippine General Hospital, Manila

1102

St Lukes Medical Center, Quezon

4217

Mary Mediatrix Medical Center, Lipa City

10330

King Chulalongkorn Memorial Hospital, Pathum Wan

10700

Siriraj Hospital, Bangkok

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

28007

Hospital General Universitario Gregorio Marañon, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28046

Hospital Universitario La Paz, Madrid

30450

Hospital Raja Permaisuri Bainun, Ipoh

37007

Hospital Universitario de Salamanca, Salamanca

45147

Universitaetsklinkm, Essen

48013

Hospital de Basurto, Bilbao

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

55139

Ondokuz Mayis Univ. Med. Fac., Samsun

59037

Hopital Claude Huriez - CHU Lille, Lille

64718

Global Trial Research Center S.A. de C.V., Monterrey

68000

Hospital Ampang, Ampang

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

89081

Universitaetsklinikum Ulm, Ulm

100730

Peking Union Medical College Hospital, Beijing

119074

National University Hospital, Singapore

169856

Singapore General Hospital, Singapore

200040

Huashan Hospital, Fudan University, Shanghai

200143

Spitalul Clinic Municipal Filantropia Craiova, Craiova

210029

Jiangsu Province Hospital, Nanjing

226001

Affiliated Hospital of Nantong University, Nantong

310003

The First Affiliated Hospital, Zhejiang University, Hangzhou

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

510515

Nanfang Hospital, Southern Medical University, Guangzhou

C1015ABO

Organizacion Medica de Investigacion (OMI), Ciudad Autonoma Buenos Aires

80810-050

Centro Integrado de Oncologia de Curitiba, Curitiba

09060-870

*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André

01321-00

Beneficencia Portuguesa de Sao Paulo, São Paulo

570 10

General Hospital of Thessaloniki G. Papanikolaou, Thessaloniki

060-8543

Sapporo Medical University Hospital, Hokkaido

305-8576

University of Tsukuba Hospital, Ibaraki

141-8625

NTT Medical Center Tokyo, Tokyo

1105 AZ

Amsterdam UMC, Locatie AMC, Amsterdam

85-168

Szpital Uniwersytecki nr2 im. dr J. Biziela, Bydgoszcz

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1, Lublin

60-185

Pratia Poznan, Skórzewo

02-172

MTZ Clinical Research Powered by Pratia, Warsaw

1099-023

Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE, Lisbon

050098

Spitalul Universitar de Urgenta Bucuresti, Bucharest

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08916

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

08036

Hospital Clinic de Barcelona, Barcelona

DUMMY_VALUE

Chang Gung Medical Foundation - Kaohsiung, Kaohisung

02091

Medical Center OK!Clinic+, Kyiv

LS9 7TF

St James University Hospital, Leeds

SE5 9RS

Kings College Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY