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New IV drug aims to control bleeding risk in rare blood disorder

NCT ID NCT06544499

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an investigational IV drug called efgartigimod in adults with primary immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, raising bleeding risk. About 69 participants will receive either the drug or a placebo for up to 24 weeks, then all may receive the drug for up to 2 years. The goal is to see if the drug safely helps maintain safe platelet levels.

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 69 people

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

Started

Oct 2024

Expected to finish

Jun 2028

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

18 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: * Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF). * Has documented baseline mean platelet count of \<30 x 10\^9/L before randomization * Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature. * Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab. * Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol). * Has documented prior response defined as 1 platelet count of ≥50 × 109/L to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin Exclusion Criteria: * Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, confound the results of the study or put the participant at undue risk. * Secondary ITP * Nonimmune thrombocytopenia * Autoimmune hemolytic anemia * ITP-associated critical or severe bleeding The complete list of criteria can be found in the protocol.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura primary thrombocytopenia Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

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

Primary immune thrombocytopenia (ITP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    93 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • A.O.U. Citta della Salute e della Scienza di Torino

    RECRUITING

    Torino, 10126, Italy

  • AO Maggiore Della Carita

    RECRUITING

    Novara, 28100, Italy

  • AO Ordine Mauriziano di Torino

    RECRUITING

    Torino, 10128, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • ASST Sette Laghi Ospedale di circolo e Fondazione Macchi

    RECRUITING

    Varese, 21100, Italy

    Contact Email: •••••@•••••

  • Acibadem City clinic Tokuda hospital

    RECRUITING

    Sofia, 1407, Bulgaria

  • Affiliated Hospital of Jiangsu University

    RECRUITING

    Zhenjiang, 212001, China

  • Allgemeines Krankenhaus der Stadt Linz

    RECRUITING

    Linz, 4020, Austria

  • Arcispedale Santa Maria Nuova (ASMN) Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

    RECRUITING

    Reggio Emilia, 42123, Italy

    Contact Email: •••••@•••••

  • Azienda Sanitaria Universitaria Integrata

    RECRUITING

    Trieste, 34125, Italy

  • Azienda ULSS 7 Pedemontana

    RECRUITING

    Bassano del Grappa, 36061, Italy

  • Barts and the London Pathology & Pharmacy Building - Barts Health NHS Trust

    RECRUITING

    London, E1 2ES, United Kingdom

  • Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University

    RECRUITING

    Beijing, 100050, China

  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

    RECRUITING

    Bradford, BD9 6RJ, United Kingdom

    Contact Email: •••••@•••••

  • Brody School of Medicine at East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • CHU d'Amiens-Picardie - Hopital SUD

    RECRUITING

    Amiens, 80054, France

  • Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • Centre Hospitalier Universitaire Dijon Bourgogne Medecine Interne et Immunologie Clinique

    RECRUITING

    Dijon, 21079, France

  • Clinical Center of Nis

    RECRUITING

    Niš, 18000, Serbia

  • Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Research Alliance Inc.

    TERMINATED

    Westbury, New York, 11590, United States

  • Complejo Hospitalario Universitario A Coruna

    RECRUITING

    A Coruña, 15006, Spain

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fakultni Nemocnice Ostrava

    RECRUITING

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, 100 34, Czechia

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • General Hospital Djordje Joanovic

    RECRUITING

    Zrenjanin, 23101, Serbia

    Contact Email: •••••@•••••

  • Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Glasgow Royal Infirmary - North Glasgow University Hospital Division

    RECRUITING

    Glasgow, G4 0ET, United Kingdom

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    RECRUITING

    Győr, 9024, Hungary

  • Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Clinico Universitario - University of Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Huizhou Central People's Hospital

    RECRUITING

    Huizhou, China

  • INTEGRIS Cancer Institute of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73109, United States

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    RECRUITING

    Tianjin, 300020, China

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

    Contact Email: •••••@•••••

  • Klinikum Kreuzschwestern Wels

    RECRUITING

    Wels, 4600, Austria

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, D07 R2WY, Ireland

    Contact Email: •••••@•••••

  • Mayo Clinic Hospital Scottsdale

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • NZOZ Neuromed M. i M. Nastaj Sp.P.

    RECRUITING

    Lublin, 20-064, Poland

    Contact Email: •••••@•••••

  • National Specialized Hospital for Active Treatment of Hematology Diseases

    RECRUITING

    Sofia, 1797, Bulgaria

  • Ohio State University Hospital East

    RECRUITING

    Columbus, Ohio, 43203, United States

  • Ordensklinikum Linz GmbH Elisabethinen

    RECRUITING

    Linz, 4020, Austria

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40-519, Poland

  • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Regional Cancer Care Associates, LLC (RCCA)

    RECRUITING

    Little Silver, New Jersey, 07739, United States

  • Royal Cornwall Hospital (RCH)

    RECRUITING

    Truro, TR1 3LJ, United Kingdom

  • Semmelweis University-Internal Medicine and Haematology

    RECRUITING

    Budapest, 1088, Hungary

  • Sharp Memorial Hospital

    RECRUITING

    Oceanside, California, 92056, United States

  • Spitalul Clinic Colentina

    RECRUITING

    Bucharest, 20125, Romania

    Contact Email: •••••@•••••

  • Spitalul Clinic Coltea, Clinica de Hematologie

    RECRUITING

    Bucharest, 030171, Romania

    Contact Email: •••••@•••••

  • Spitalul Clinic Judetean de Urgenta Sibiu (SCJS) (Clinical County Hospital Sibiu)

    RECRUITING

    Sibiu, 550245, Romania

    Contact Email: •••••@•••••

  • Spitalul Clinic Judetean de Urgenta Targu-Mures

    RECRUITING

    Târgu Mureş, 540136, Romania

    Contact Email: •••••@•••••

  • St James's Hospital - Cancer Clinical Trials Office

    RECRUITING

    Dublin, D08 NHY1, Ireland

    Contact Email: •••••@•••••

  • Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu

    RECRUITING

    Nowy Sącz, 33-300, Poland

    Contact Email: •••••@•••••

  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

    RECRUITING

    Bydgoszcz, 85-168, Poland

  • The Affiliated Hospital of Chengde Medical University

    RECRUITING

    Chengde, 067020, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    RECRUITING

    Hohhot, 010050, China

  • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

    RECRUITING

    Huai'an, 223300, China

  • The First Affiliated Hospital Of Bengbu Medical College

    RECRUITING

    Bengbu, 233004, China

  • The University of Chicago Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • The University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Tulane University

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • U.O.C. Ematologia Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • UMHAT Aleksandrovska

    RECRUITING

    Sofia, 1431, Bulgaria

  • UMHAT SofiaMed

    RECRUITING

    Sofia, 1797, Bulgaria

  • Unidade Local de Saude Gaia e Espinho, E.P.E.

    RECRUITING

    Vila Nova de Gaia, 4434-502, Portugal

  • Unidade Local de Saude de Braga

    RECRUITING

    Braga, 4710, Portugal

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

    RECRUITING

    Wuhan, China

  • Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)

    RECRUITING

    Florence, 50134, Italy

  • Universitaetsklinikum Essen (AoR)

    RECRUITING

    Essen, 45147, Germany

  • University Clinical Centre of Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Hospital Center Zemun

    RECRUITING

    Zemun, 11080, Serbia

  • University Hospital Carl Gustav Carus

    RECRUITING

    Dresden, 01307, Germany

    Contact Email: •••••@•••••

  • University Hospital Center Zagreb

    RECRUITING

    Zagreb, 10000, Croatia

  • University Hospital Prof. Dr. Stoyan Kirkovich AD

    RECRUITING

    Stara Zagora, 6003, Bulgaria

  • University Hospital Quironsalud Madrid

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Hospitals Coventry and Warwickshire NHS Trust

    RECRUITING

    Coventry, CV2 2DX, United Kingdom

  • University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski

    RECRUITING

    Sofia, 1431, Bulgaria

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55422, United States

  • University of Southern California Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie Centrum Innowacyjnych Terapii

    RECRUITING

    Lublin, 20-090, Poland

  • Wojewodzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu

    RECRUITING

    Torun, 87-100, Poland

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    RECRUITING

    Lodz, 93-513, Poland

    Contact Email: •••••@•••••

  • Wuxi People's Hospital (Wuxi No.1 People's Hospital)

    RECRUITING

    Wuxi, 214023, China

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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