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New PNH drug crovalimab faces off against eculizumab in phase 3 trial

NCT ID NCT04432584

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This phase 3 trial compares crovalimab, a new injectable drug, to eculizumab in about 190 people with paroxysmal nocturnal hemoglobinuria (PNH) who are already on complement inhibitors. The study aims to see if crovalimab is as safe and effective, with a focus on side effects and how the body processes the drug. Participants will receive either crovalimab or continue eculizumab, and the results could lead to a more convenient treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Crovalimab (a drug given by injection under the skin or into a vein)
What this could lead to
If it works, crovalimab could offer a more convenient treatment option for people with PNH, potentially requiring fewer injections than current therapies.
What could go wrong
This is a phase 3 trial, but it's comparing two similar drugs, so the benefit over eculizumab may be small. Risks include injection-site reactions, infections, and possible drug interactions when switching treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 190 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hemoglobinuria, Paroxysmal paroxysmal nocturnal hemoglobinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paroxysmal nocturnal hemoglobinuria

Contacts and locations

Locations

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

    Santo André, São Paulo, 09060-870, Brazil

  • AZ Delta Campus Westlaan

    Roeselare, 8800, Belgium

  • Akademiska Sjukhuset

    Uppsala, 751 85, Sweden

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Attikon University General Hospital

    Athens, 124 62, Greece

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Azienda Unita Sanitaria Locale- Ravenna

    Ravenna, Emilia-Romagna, 48121, Italy

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01321-00, Brazil

  • Carolinas Healthcare System

    Charlotte, North Carolina, 28204, United States

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

    Aveiro, 3814-501, Portugal

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001, Portugal

  • Changhua Christian Hospital

    Chang-hua, 500, Taiwan

  • Chronos Pesquisa Clinica

    Taguatinga, Federal District, 72145-450, Brazil

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706, Spain

  • ELBLANDKLINIKUM Riesa

    Riesa, 01589, Germany

  • Ege University Medical Faculty; Hematology

    Izmir, 35040, Turkey (Türkiye)

  • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Fujita Health University Hospital

    Aichi, 470-1192, Japan

  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology

    Gaziantep, 27310, Turkey (Türkiye)

  • General Hospital of Athens LAIKO

    Athens, 115 27, Greece

  • Hacettepe University Medical Faculty; Neurology

    Ankara, 06100, Turkey (Türkiye)

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037, France

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Paulistano

    São Paulo, São Paulo, 01321-000, Brazil

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital U. Central de Asturias

    Asturias, Principality of Asturias, 33011, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Universitario de Toledo

    Toledo, 45007, Spain

  • Hospital das Clínicas FMRP-USP

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hualien Tzu Chi Hospital

    Hualien City, DUMMY_VALUE, Taiwan

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Institut Paoli Calmette

    Marseille, 13273, France

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina, 89201-260, Brazil

  • Ishikawa Prefectural Central Hospital

    Ishikawa, 920-8530, Japan

  • Istanbul University Istanbul Medical Faculty; Neurology

    Istanbul, 34093, Turkey (Türkiye)

  • Iwate Prefectural Isawa Hospital

    Ōshū, 023-0864, Japan

  • Japanese Red Cross Society Suwa Hospital

    Nagano, 392-8510, Japan

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211, Saudi Arabia

  • King'S College Hospital

    London, SE5 9RS, United Kingdom

  • Kobe University Hospital

    Hyōgo, 650-0017, Japan

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172, Poland

  • Marmara University Pendik Training and Research Hospital, Hematology Department

    Istanbul, 34300, Turkey (Türkiye)

  • Mie University Hospital

    Mie, 514-8507, Japan

  • NTT Medical Center Tokyo

    Tokyo, 141-8625, Japan

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • National Taiwan Universtiy Hospital

    Taipei, 100, Taiwan

  • National University Hospital

    Singapore, 117599, Singapore

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • North Estonia Medical Centre Foundation

    Tallinn, 13419, Estonia

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139, Turkey (Türkiye)

  • Pratia Poznan

    Skórzewo, 60-185, Poland

  • Prince of Wales Hospital

    Hong Kong, 999077, Hong Kong

  • Samodzielny Publiczny Szpital Kliniczny nr 1

    Lublin, 20-081, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Sasebo City General Hospital

    Nagasaki, 857-8511, Japan

  • Semmelweis Egyetem

    Budapest, 1088, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • St James's Hospital

    Dublin, D08NYH1, Ireland

  • Szpital Uniwersytecki nr2 im. dr J. Biziela

    Bydgoszcz, 85-168, Poland

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • Tokai University Hospital

    Kanagawa, 259-1193, Japan

  • Tokushukai Takasago Seibu Hospital

    Hyōgo, 676-0812, Japan

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Toyama Prefectual Central Hospital

    Toyama, 930-8550, Japan

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • Universitaetsklinikum Aachen AOeR

    Aachen, 52074, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Ustav hematologie a krevni transfuze

    Prague, 128 00, Czechia

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