A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of Participants With Adverse Events (AEs) and by Severity — Up to approximately 6 years
Severity determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5). - Percentage of Participants With Injection-site Reactions, Infusion-related Reactions, Hypersensitivity and Infections (including Meningococcal Meningitis) — Up to approximately 6 years
- Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation — Up to approximately 6 years
- Percentage of Participants With Clinical Manifestations of Drug-target-drug Complex (DTDC) Formation Amongst Those Participants Who Switched to Crovalimab Treatment From Eculizumab Treatment or Ravulizumab Treatment — Up to approximately 6 years
Trial sites (80)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Spain
Other trials for the same condition
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 Spain