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ACTIVE NOT RECRUITING

NCT04434092

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.

Official title: A Phase III, Randomized, Open-label, Active-controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2020-10-08

Completion Date

2027-09-30

Last Updated

2026-02-17

Healthy Volunteers

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.

Inclusion Criteria: * Body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg) * Willingness and ability to comply with all study visits and procedures * Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry * LDH level ≥ 2x ULN at screening (as per local assessment) * Vaccination against Neisseria meningitidis serotypes A, C, W, and Y\< 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration * Women of childbearing potential: agreement to remain abstinent 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 dose of eculizumab (or longer if required by the local product label) Exclusion Criteria: * Current or previous treatment with a complement inhibitor * History of allogeneic bone marrow transplantation * History of Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration * History of myelodysplastic syndrome with Revised International Prognostic Scoring System (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 of eculizumab (or longer if required by the local product label) * Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater * Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the Investigator, preclude the participant's safe participation in and completion of the study * Splenectomy \< 6 months before screening * Positive for Active Hepatitis B and C infection (HBV/HCV) * History of or ongoing cryoglobulinemia at screening

Locations (63)

Organizacion Medica de Investigacion (OMI)

Ciudad Autonoma Buenos Aires, Argentina

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

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

Santo André, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo

São Paulo, Brazil

Peking Union Medical College Hospital

Beijing, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Jiangsu Province Hospital

Nanjing, China

Affiliated Hospital of Nantong University

Nantong, China

Huashan Hospital, Fudan University

Shanghai, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Centre Hospitalier Lyon Sud

Pierre-Bnite, Rhone, France

Hopital Claude Huriez - CHU Lille

Lille, France

Universitaetsklinkm

Essen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

General Hospital of Thessaloniki G. Papanikolaou

Thessaloniki, Greece

Sapporo Medical University Hospital

Hokkaido, Japan

University of Tsukuba Hospital

Ibaraki, Japan

NTT Medical Center Tokyo

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Vilnius University Hospital Santariskiu Clinics, Public Institution

Vilnius, Lithuania

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Hospital Ampang

Ampang, Selangor, Malaysia

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico CITY (federal District), Mexico

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

Monterrey, Nuevo León, Mexico

Amsterdam UMC, Locatie AMC

Amsterdam, Netherlands

Mary Mediatrix Medical Center

Lipa City, Philippines

Philippine General Hospital

Manila, Philippines

St Lukes Medical Center

Quezon, Philippines

Szpital Uniwersytecki nr2 im. dr J. Biziela

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1

Lublin, Poland

Pratia Poznan

Skórzewo, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

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

Aveiro, Portugal

Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

Lisbon, Portugal

Centro Hospitalar do Porto - Hospital de Santo António

Porto, Portugal

Spitalul Universitar de Urgenta Bucuresti

Bucharest, Romania

Spitalul Clinic Municipal Filantropia Craiova

Craiova, Romania

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital de Basurto

Bilbao, Albacete, Spain

ICO Badalona - Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, LAS Palmas, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Clinico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Chang Gung Medical Foundation - Kaohsiung

Kaohisung, Taiwan

National Taiwan Universtiy Hospital

Taipei, Taiwan

Siriraj Hospital

Bangkok, Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

King Chulalongkorn Memorial Hospital

Pathum Wan, Thailand

Ondokuz Mayis Univ. Med. Fac.

Samsun, Turkey (Türkiye)

Medical Center OK!Clinic+

Kyiv, KIEV Governorate, Ukraine

St James University Hospital

Leeds, United Kingdom

Kings College Hospital

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)