A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
NCT ID: NCT07194850
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
24 participants
INTERVENTIONAL
2025-10-20
2030-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efgartigimod IV
Participants receiving efgartigimod IV during the double-blinded treatment period and the open-label treatment period(s)
Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Participants receiving placebo IV during the double-blinded treatment period and receiving efgartigimod IV during the open-label treatment period(s)
Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Intravenous infusion of placebo
Interventions
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Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Intravenous infusion of placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* Nonimmune thrombocytopenia
* ITP-associated critical or severe bleeding
* History of hereditary thrombocytopenia
12 Years
17 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, , Poland
Institutul Clinic Fundeni
Bucharest, , Romania
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
Cardiff and Vale NHS Trust - University Hospital of Wales (UHW)
Cardiff, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ARGX-113-2409
Identifier Type: -
Identifier Source: org_study_id
2025-521055-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
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