Actively Recruiting
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Led by argenx · Updated on 2026-04-20
24
Participants Needed
8
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 12 to less than 18 years at consent
- Diagnosed with primary chronic immune thrombocytopenia (ITP) for more than 12 months
- Prior treatment for ITP with corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonists, or rituximab
- Prior platelet count response of at least 50 x 10^9/L to prednisone, corticosteroids, IVIg, or anti-D immunoglobulin
- Insufficient response to prior ITP treatments including corticosteroids, IVIg, anti-D immunoglobulin, TPO receptor agonists, rituximab, or splenectomy
- Mean platelet count less than 30 x 10^9/L
You will not qualify if you...
- Secondary immune thrombocytopenia (all forms except primary ITP)
- Nonimmune thrombocytopenia
- Critical or severe bleeding related to ITP
- History of hereditary thrombocytopenia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
Gaslini Children's Hospital
Genoa, Italy, 16147
Actively Recruiting
2
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, Poland, 20-093
Actively Recruiting
3
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Actively Recruiting
4
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
5
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
6
Hospital Infantil Universitario Nino Jesus (HIUNJS)
Madrid, Spain, 28009
Actively Recruiting
7
Hospital Materno-Infantil Universitario Gregorio Maranon
Madrid, Spain, 28009
Actively Recruiting
8
Cardiff and Vale NHS Trust - University Hospital of Wales (UHW)
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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