A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

Last updated: February 10, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Proteinuria

Anemia

Bone Marrow Disorder

Treatment

Eculizumab

Crovalimab

Clinical Study ID

NCT04432584
BO42161
2020-000597-26
  • All Genders

Study Summary

A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body weight >= 40 kg at screening.

  • Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.

  • Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.

  • Willingness and ability to comply with all study visits and procedures.

  • Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.

  • Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years priorto initiation of study treatment; or, if not previously done, vaccinationadministered no later than one week after the first drug administration.

  • Women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final doseof eculizumab (or longer if required by the local product label).

Exclusion

Exclusion Criteria:

  • History of allogeneic bone marrow transplantation.

  • History of myelodysplastic syndrome with Revised International Prognostic ScoringSystem (IPSS-R) prognostic risk categories of intermediate, high and very high.

  • Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose ofeculizumab (or longer if required by the local product label).

  • Participation in another interventional treatment study with an investigationalagent or use of any experimental therapy within 28 days of screening or within 5half-lives of that investigational product, whichever was greater: participantsenrolled in an eculizumab or ravulizumab interventional study are eligible providedthey fulfill eligibility (e.g., are willing and able to comply with the studyassessments) and stop their participation in current trial beforerandomisation/enrolment.

  • Positive for Active Hepatitis B and C infection (HBV/HCV).

  • Concurrent disease, treatment, procedure, or surgery or abnormality in clinicallaboratory tests that could interfere with the conduct of the study, may pose anyadditional risk for the participant, or would, in the opinion of the investigator,preclude the participant's safe participation in and completion of the study.

  • History of or ongoing cryoglobulinemia at screening.

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Eculizumab
Phase: 3
Study Start date:
September 30, 2020
Estimated Completion Date:
September 01, 2029

Connect with a study center

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Westmead Hospital; Pharmacy

    Northmead, New South Wales 2145
    Australia

    Site Not Available

  • Liverpool Hospital

    Sydney, New South Wales 2080
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc; Pharmacy

    Bruxelles, 1200
    Belgium

    Site Not Available

  • AZ Delta Campus Westlaan

    Roeselare, 8800
    Belgium

    Site Not Available

  • CHU UCL Namur / site Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

  • Hospital Universitario Walter Cantidio - UFC

    Fortaleza, CE 60430-370
    Brazil

    Site Not Available

  • Nucleo de Pesquisa Clinica do Hospital da Crianca

    Brasilia, DF 70684-831
    Brazil

    Site Not Available

  • Chronos Pesquisa Clinica

    Taguatinga, Distrito Federal 72145-450
    Brazil

    Site Not Available

  • Elo Clinical Research

    Maringa, PA 87015-200
    Brazil

    Site Not Available

  • Centro Integrado de Oncologia de Curitiba

    Curitiba, PR 80810-050
    Brazil

    Site Not Available

  • Hrpc - Health Clinical Research Representation - Eireli

    Canoas, RS 92010-170
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90020-090
    Brazil

    Site Not Available

  • Fundação Doutor Amaral Carvalho

    JAU, SP 17210-120
    Brazil

    Site Not Available

  • *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, SP 09060-650
    Brazil

    Site Not Available

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina 89201-260
    Brazil

    Site Not Available

  • Hospital das Clínicas FMRP-USP

    Ribeirao Preto, São Paulo 14048-900
    Brazil

    Site Not Available

  • *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo Andre, São Paulo 09060-870
    Brazil

    Site Not Available

  • Hospital Paulistano

    Sao Paulo, São Paulo 01321-000
    Brazil

    Site Not Available

  • Hospital Sírio-Libanês

    Sao Paulo, São Paulo 01308-050
    Brazil

    Site Not Available

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01321-00
    Brazil

    Site Not Available

  • CISSS Chaudière-Appalaches

    Levis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • CHUQ - Hôtel-Dieu de Québec

    Ste-Foy, Quebec G1V 4G2
    Canada

    Site Not Available

  • Fundacion Santa Fe de Bogota

    Bogota, 110111
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellin, 050034
    Colombia

    Site Not Available

  • Ustav hematologie a krevni transfuze

    Praha, 128 00
    Czechia

    Site Not Available

  • North Estonia Medical Centre Foundation

    Tallinn, 13419
    Estonia

    Site Not Available

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037
    France

    Site Not Available

  • Hopital Claude Huriez - CHU Lille

    Lille cedex, 59037
    France

    Site Not Available

  • Institut Paoli Calmette; Service d'Hématologie Clinique

    Marseille, 13273
    France

    Site Not Available

  • CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique

    Rennes cedex 9, 35033
    France

    Site Not Available

  • Universitaetsklinikum Aachen AOeR

    Aachen, 52074
    Germany

    Site Not Available

  • Universitaetsklinikum

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Universitaetsklinikum

    Essen, 45147
    Germany

    Site Not Available

  • ELBLANDKLINIKUM Riesa

    Riesa, 01589
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Attikon University General Hospital

    Ahens, 124 64
    Greece

    Site Not Available

  • University General Hospital of Alexandroupolis

    Alexandroupolis, 681 00
    Greece

    Site Not Available

  • Attikon University General Hospital

    Athens, 124 62
    Greece

    Site Not Available

  • General Hospital of Athens LAIKO

    Athens, 115 27
    Greece

    Site Not Available

  • Attikon University General Hospital

    Chaidari, 124 62
    Greece

    Site Not Available

  • University General Hospital of Larissa

    Larissa, 412 21
    Greece

    Site Not Available

  • AHEPA General Hospital of Thessaloniki

    Thessaloniki, 546 36
    Greece

    Site Not Available

  • General Hospital of Thessaloniki G. Papanikolaou

    Thessaloniki, 57010
    Greece

    Site Not Available

  • General Hospital of Athens LAIKO

    Αθηνα, 115 27
    Greece

    Site Not Available

  • The Chinese University of Hong Kong

    Shatin, DUMMY_VALUE
    Hong Kong

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Site Not Available

  • Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088
    Hungary

    Site Not Available

  • St James's Hospital

    Dublin, D08X4RX
    Ireland

    Site Not Available

  • Rambam Health Care Center

    Haifa, 91096
    Israel

    Site Not Available

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Campania 83100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Azienda Unita Sanitaria Locale- Ravenna

    Ravenna, Emilia-Romagna 48121
    Italy

    Site Not Available

  • Azienda Ospedaliera Sant'Andrea

    Roma, Lazio 00189
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio 00168
    Italy

    Site Not Available

  • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

    Catania, Sicilia 95123
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Toscana 50134
    Italy

    Site Not Available

  • Ospedale Di Vicenza; Nefrologia, Ematologia

    Vicenza, Veneto 36100
    Italy

    Site Not Available

  • Fujita Health University Hospital

    Aichi, 470-1192
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima, 960-1295
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543
    Japan

    Site Not Available

  • Kobe University Hospital

    Hyogo, 650-0017
    Japan

    Site Not Available

  • Kobe University Hospital; Medical Oncology and Hematology

    Hyogo, 650-0017
    Japan

    Site Not Available

  • Tokushukai Takasago Seibu Hospital

    Hyogo, 676-0812
    Japan

    Site Not Available

  • University of Tsukuba Hospital

    Ibaraki, 305-8576
    Japan

    Site Not Available

  • Ishikawa Prefectural Central Hospital

    Ishikawa, 920-8530
    Japan

    Site Not Available

  • Tokai University Hospital

    Kanagawa, 259-1193
    Japan

    Site Not Available

  • Mie University Hospital

    Mie, 514-8507
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Miyagi, 960-1295
    Japan

    Site Not Available

  • Japanese Red Cross Society Suwa Hospital

    Nagano, 392-8510
    Japan

    Site Not Available

  • Nagasaki University Hospital

    Nagasaki, 852-8501
    Japan

    Site Not Available

  • Sasebo City General Hospital

    Nagasaki, 857-8511
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Site Not Available

  • Iwate Prefectural Isawa Hospital

    Oshu, 023-0864
    Japan

    Site Not Available

  • NTT Medical Center Tokyo

    Tokyo, 141-8625
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Toyama Prefectual Central Hospital

    Toyama, 930-8550
    Japan

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Severance Hospital; Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Site Not Available

  • Global Trial Research Center S.A. de C.V.

    Monterrey, Nuevo LEON 64718
    Mexico

    Site Not Available

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Radboudumc

    NL -nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Szpital Uniwersytecki nr2 im. dr J. Biziela

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

    Gdansk, 80-952
    Poland

    Site Not Available

  • SPZOZ Szpital Uniw W Krakowie

    Krakow, 31-501
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1

    Lublin, 20-081
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Poznan

    Skórzewo, 60-185
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by Pratia

    Warszawa, 02-172
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-556
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1

    Zabrze, 44803
    Poland

    Site Not Available

  • Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro

    Aveiro, 3814-501
    Portugal

    Site Not Available

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001
    Portugal

    Site Not Available

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211
    Saudi Arabia

    Site Not Available

  • National University Hospital

    Singapore, 117599
    Singapore

    Site Not Available

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 826 06
    Slovakia

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Sant Joan De Deu

    Esplugues De Llobregas, Barcelona 08950
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna 15706
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria

    Las Palmas de Gran Canaria, LAS Palmas 35019
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital de Basurto

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital U. Central de Asturias

    Asturias, 33011
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital San Pedro de Alcantara

    Caceres, 10003
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria

    Las Palmas, 35010
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Complejo Hospitalario de Toledo

    Toledo, 45004
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Akademiska Sjukhuset

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Changhua Christian Hospital

    Chang Hua, 500
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Hospital

    Hualien, DUMMY_VALUE
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Hospital; Hematology and oncology

    Hualien,
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Hospital; Hematology and oncology

    Hualien City, 97002
    Taiwan

    Site Not Available

  • Chi Mei Medical Center Liou Ying Campus

    Liuying Township, 736
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital; Hematology and oncology

    Taipei, 10449
    Taiwan

    Active - Recruiting

  • National Taiwan Universtiy Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • National Taiwan Universtiy Hospital; Division of Hematology

    Taipei, 100
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital; Hematology and oncology

    Zhongshan Dist., 10449
    Taiwan

    Site Not Available

  • Hacettepe University Medical Faculty; Neurology

    Ankara, 06100
    Turkey

    Site Not Available

  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology

    Gaziantep, 27310
    Turkey

    Site Not Available

  • Istanbul University Istanbul Medical Faculty; Neurology

    Istanbul, 34093
    Turkey

    Site Not Available

  • Marmara University Pendik Training and Research Hospital, Hematology Department

    Istanbul, 34300
    Turkey

    Site Not Available

  • Ege University Medical Faculty; Hematology

    Izmir, 35040
    Turkey

    Site Not Available

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139
    Turkey

    Site Not Available

  • Monklands Hospital; Haematology

    Airdrie, ML6 0JS
    United Kingdom

    Site Not Available

  • St James's Institute of Oncology; Dept of Haematology

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • King'S College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • King'S College Hospital; Haematology

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • The Oncology Institute of Hope and Innovation

    Anaheim, California 92801
    United States

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • David Geffen School of Medicine UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of Florida College of Medicine

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Indiana Blood & Marrow Transplantation, LLC

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • West Michigan Cancer Center

    Kalamazoo, Michigan 49007
    United States

    Site Not Available

  • Henry Ford Hospital; Henry Ford Medical Center

    West Bloomfield, Michigan 48322
    United States

    Site Not Available

  • Upstate University Hospital; SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Carolinas Healthcare System

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Nationwide Children's Hospital; Dept. of Pulmonology

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Cook Childrens Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin 53226-3596
    United States

    Site Not Available

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