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Clinical Trials in the UK / NCT04432584
Active, not recruiting Phase 3

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

NCT04432584 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2020-09-30
Last updated
2026-07-28

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Investigational drug(s) / intervention(s)

CrovalimabEculizumab

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.

Eculizumab: Eculizumab will be administered at a dose of 900 mg Q2W, as per the dosing schedule described above.

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

Sex
ALL
Min age
2 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg) * 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 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 (refrain from heterosexual 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 dose of eculizumab (or longer if required by the local product label) Exclusion Criteria: * History of allogeneic bone marrow transplantation * 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 was greater: participants enrolled in an eculizumab or ravulizumab interventional study are eligible provided they fulfill eligibility (e.g., are willing and able to comply with the study assessments) and stop their participation in current trial before randomisation/enrolment * Positive for Active Hepatitis B and C infection (HBV/HCV) * 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 * History of or ongoing cryoglobulinemia at screening

Primary outcome measure(s)

Trial sites (80)

FacilityCityRegionStatus
Carolinas Healthcare System Charlotte North Carolina
Nationwide Children's Hospital Columbus Ohio
Cliniques Universitaires Saint-Luc Brussels Belgium
AZ Delta Campus Westlaan Roeselare Belgium
Chronos Pesquisa Clinica Taguatinga Federal District
Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul
Hospital de Clínicas de Porto Alegre X Porto Alegre Rio Grande do Sul
Instituto Joinvilense de Hematologia E Oncologia Joinville Santa Catarina
Hospital das Clínicas FMRP-USP Ribeirão Preto São Paulo
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia Santo André São Paulo
Hospital Sírio-Libanês São Paulo São Paulo
Hospital Paulistano São Paulo São Paulo
Beneficencia Portuguesa de Sao Paulo São Paulo Brazil
Ustav hematologie a krevni transfuze Prague Czechia
North Estonia Medical Centre Foundation Tallinn Estonia
Hopital Claude Huriez - CHU Lille Lille France
Institut Paoli Calmette Marseille France
Universitaetsklinikum Aachen AOeR Aachen Germany
ELBLANDKLINIKUM Riesa Riesa Germany
General Hospital of Athens LAIKO Athens Greece
Attikon University General Hospital Athens Greece
Prince of Wales Hospital Hong Kong Hong Kong
Semmelweis Egyetem Budapest Hungary
St James's Hospital Dublin Ireland
Azienda Unita Sanitaria Locale- Ravenna Ravenna Emilia-Romagna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio
Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico Milan Lombardy
Azienda Ospedaliera Città della Salute e della Scienza di Torino Turin Piedmont
Azienda Ospedaliera Universitaria Careggi Florence Tuscany
Fujita Health University Hospital Aichi Japan
Kobe University Hospital Hyōgo Japan
Tokushukai Takasago Seibu Hospital Hyōgo Japan
Ishikawa Prefectural Central Hospital Ishikawa Japan
Tokai University Hospital Kanagawa Japan
Mie University Hospital Mie Japan
Japanese Red Cross Society Suwa Hospital Nagano Japan
Nagasaki University Hospital Nagasaki Japan
Sasebo City General Hospital Nagasaki Japan
National Hospital Organization Okayama Medical Center Okayama Japan
The University of Osaka Hospital Osaka Japan

+ 40 more sites — see the full list on the official registry below.

On this site

📄 Soliris (eculizumab) drug profile →

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04432584 on ClinicalTrials.gov ↗ ← All trials in the UK