Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2/Phase3

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

Sponsor: argenx

NCT ID: NCT07194850

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Efgartigimod IV (biological), Placebo IV (other)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Efgartigimod IV — biological: Intravenous infusion of efgartigimod · Placebo IV — other: Intravenous infusion of placebo
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years to 17 Years
Who
All
Number of participants
24
Started
2025-10-20
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immune thrombocytopenia (itp)
  • • Phase2/Phase3 - 24 participants
  • • 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)

Who can take part?

  • • Ages 12 Years to 17 Years
  • • Diagnosed with immune thrombocytopenia (itp)

Where?

  • • Cardiff - Cardiff and Vale NHS Trust - University Hospital of Wales (UHW)
  • • Glasgow - The Royal Hospital for Children - Glasgow Health Board
  • • Manchester - Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Immune Thrombocytopenia (ITP)ITP - Immune ThrombocytopeniaITPImmune Thrombocytopenic PurpuraImmune Thrombocytopenic Purpura ( ITP )Idiopathic Thrombocytopenic PurpuraIdiopathic Thrombocytopenic Purpura (ITP)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years - 17 Years
  • Who can join: All genders

What the study is looking for

  • ✓Is aged 12 to less than 18 years when completing the agreement to take part process
  • ✓Has a documented duration of primary ITP of more than 12 months on the date the agreement to take part process is complete
  • ✓Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D...
  • ✓Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin,...
  • ✓Has documented mean blood clotting cell count of less than 30 x10\^9/L

Who cannot take part

  • ✗Secondary ITP according to the following definition by the International Working Group (IWG): all forms of...
  • ✗Nonimmune thrombocytopenia
  • ✗ITP-associated critical or severe bleeding
  • ✗History of hereditary thrombocytopenia
See the full 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

Where Is This Study? (3 UK sites)

Cardiff and Vale NHS Trust - University Hospital of Wales (UHW)

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)

The Royal Hospital for Children - Glasgow Health Board

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Sarah Clarke, MDsarah.clarke2@nhs.scot

Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

Manchester M139WL, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Sabine Coppieters, MD

Sponsor contact

CONTACT

857-350-4834 clinicaltrials@argenx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09