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New PNH drug crovalimab tested against standard care in phase 3 trial

NCT ID NCT04434092

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study tests whether crovalimab works as well as eculizumab for people with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. About 210 adults who have not had prior complement inhibitor therapy will receive either drug. The main goals are to see if crovalimab can prevent blood transfusions and control red blood cell breakdown.

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

210 people

The number who actually took part.

Started

Oct 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) * 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

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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

  • Affiliated Hospital of Nantong University

    Nantong, 226001, China

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01321-00, Brazil

  • Centre Hospitalier Lyon Sud

    Pierre-Bnite, Rhone, 69310, France

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

    Aveiro, 3810-501, Portugal

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001, Portugal

  • Chang Gung Medical Foundation - Kaohsiung

    Kaohisung, DUMMY_VALUE, Taiwan

  • General Hospital of Thessaloniki G. Papanikolaou

    Thessaloniki, 570 10, Greece

  • Global Trial Research Center S.A. de C.V.

    Monterrey, Nuevo León, 64718, Mexico

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037, France

  • Hospital Ampang

    Ampang, Selangor, 68000, Malaysia

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990, Malaysia

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30450, Malaysia

  • Hospital San Pedro de Alcantara

    Cáceres, 10003, Spain

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100, Malaysia

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, LAS Palmas, 35019, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital de Basurto

    Bilbao, Albacete, 48013, Spain

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico CITY (federal District), 14080, Mexico

  • Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

    Lisbon, 1099-023, Portugal

  • Jiangsu Province Hospital

    Nanjing, 210029, China

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172, Poland

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Mary Mediatrix Medical Center

    Lipa City, 4217, Philippines

  • Medical Center OK!Clinic+

    Kyiv, KIEV Governorate, 02091, Ukraine

  • NTT Medical Center Tokyo

    Tokyo, 141-8625, Japan

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515, China

  • National Taiwan Universtiy Hospital

    Taipei, 100, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139, Turkey (Türkiye)

  • Organizacion Medica de Investigacion (OMI)

    Ciudad Autonoma Buenos Aires, C1015ABO, Argentina

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Philippine General Hospital

    Manila, 1000, Philippines

  • Pratia Poznan

    Skórzewo, 60-185, Poland

  • Samodzielny Publiczny Szpital Kliniczny nr 1

    Lublin, 20-081, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Singapore General Hospital

    Singapore, 169856, Singapore

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143, Romania

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098, Romania

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St Lukes Medical Center

    Quezon, 1102, Philippines

  • Szpital Uniwersytecki nr2 im. dr J. Biziela

    Bydgoszcz, 85-168, Poland

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310003, China

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • Universitaetsklinkm

    Essen, 45147, Germany

  • University of Tsukuba Hospital

    Ibaraki, 305-8576, Japan

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vilnius University Hospital Santariskiu Clinics, Public Institution

    Vilnius, LT-08661, Lithuania

More trials for these conditions

Other studies related to the condition(s) this trial covers.