A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Running, not enrolling · Phase 3
Conditions studied: Paroxysmal Nocturnal Hemoglobinuria
In brief
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.
Key facts
- Study ID
- NCT04432584
- Run by
- Hoffmann-La Roche
- People needed
- 190
- Starts
- 2020-09-30
- Expected to finish
- 2027-04-18
- Last updated by the study team
- 2026-07-28
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
- AZ Delta Campus Westlaan — Roeselare, Belgium
- Chronos Pesquisa Clinica — Taguatinga, Federal District, Brazil
- Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital de Clínicas de Porto Alegre X — Porto Alegre, Rio Grande do Sul, Brazil
- Instituto Joinvilense de Hematologia E Oncologia — Joinville, Santa Catarina, Brazil
- Hospital das Clínicas FMRP-USP — Ribeirão Preto, São Paulo, Brazil
- *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia — Santo André, São Paulo, Brazil
- Hospital Sírio-Libanês — São Paulo, São Paulo, Brazil
- Hospital Paulistano — São Paulo, São Paulo, Brazil
- 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, Italy
- Carolinas Healthcare System — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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