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

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT04434092•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.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

October 8, 2020

Primary Completion Date

November 16, 2022

Completion Date

September 30, 2027

Last Updated

February 17, 2026

Enrollment

210

ACTUAL participants

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Interventions

Crovalimab

DRUG

Eculizumab

DRUG

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

NCT03520647

Severe Aplastic Anemia (SAA)Hypo-Plastic Myelodysplastic Syndrome (MDS)+1 more

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RECRUITING

National Longitudinal Cohort of Hematological Diseases

NCT04645199

Multiple MyelomaAcute Myeloid Leukemia+15 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

National Longitudinal Cohort of Hematological Diseases

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Home Reported Outcomes in PNH

Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH