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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)

Sponsor: argenx • ClinicalTrials.gov ID: NCT07194850

Registry updated: 2026-10-16
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Description

The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP). The study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (OLTP2). After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancejunior

Interventions

  • Efgartigimod IV (Biological)
    Intravenous infusion of efgartigimod
  • Placebo IV (Other)
    Intravenous infusion of placebo

Eligibility criteria

Inclusion Criteria: * Is aged 12 to less than 18 years when completing the informed consent process * Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete * Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab. * Has documented prior response, defined as 1 platelet count of ≥50 × 10\^9/L to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin * Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy * Has documented mean platelet count of less than 30 x10\^9/L Exclusion Criteria: * Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP * Nonimmune thrombocytopenia * ITP-associated critical or severe bleeding * History of hereditary thrombocytopenia

Conditions

Immune Thrombocytopenia (ITP) ITP - Immune Thrombocytopenia ITP Immune Thrombocytopenic Purpura Immune Thrombocytopenic Purpura ( ITP ) Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura (ITP)

Locations

  • Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants — Bordeaux, France
  • Centre Hospitalier Universitaire de Grenoble - Hopital Couple - Enfant — La Tronche, France
  • CHU de Nancy Hopitaux de Brabois — Vandœuvre-lès-Nancy, France
  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) — Berlin, Germany
  • Universitaetsklinikum Freiburg Kinder - Kinder- und Jugendklinik — Freiburg im Breisgau, Germany
  • Gaslini Children's Hospital — Genoa, Italy
  • Fondazione IRCCS San Gerardo dei Tintori — Monza, Italy
  • Bambino Gesu Children's Hospital — Roma, Italy
  • A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita — Torino, Italy
  • Hokkaido University Hospital — Sapporo, Hokkaido, Japan
  • Hyogo Prefectural Kobe Children's Hospital — Kobe, Hyōgo, Japan
  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital — Osaka, Osaka, Japan
  • Vilnius University Hospital Santaros Klinikos, Children's Hospital — Vilnius, Lithuania
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny nr 4 — Lodz, Poland
  • Uniwersytecki Szpital Dzieciecy w Lublinie — Lublin, Poland
  • Institutul Clinic Fundeni — Bucharest, Romania
  • Institute Of Mother And Child Healthcare Of Serbia Dr Vukan Cupic — Belgrade, Serbia
  • University Clinical Centre of Kragujevac — Kragujevac, Serbia
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital Sant Joan de Deu Barcelona — Esplugues de Llobregat, Spain
  • Hospital Infantil Universitario Nino Jesus (HIUNJS) — Madrid, Spain
  • Hospital Materno-Infantil Universitario Gregorio Maranon — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Cardiff and Vale NHS Trust - University Hospital of Wales (UHW) — Cardiff, United Kingdom
  • The Royal Hospital for Children - Glasgow Health Board — Glasgow, United Kingdom
  • Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record