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

Sponsor
argenx
Study ID
NCT07194850
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusion of efgartigimod
  • Placebo IV — OTHER
    Intravenous infusion of placebo

Study Details

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

Key Dates

Start date
Oct 20, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2030

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod IV
    Participants receiving efgartigimod IV during the double-blinded treatment period and the open-label treatment period(s)
  • Placebo Comparator: Placebo IV
    Participants receiving placebo IV during the double-blinded treatment period and receiving efgartigimod IV during the open-label treatment period(s)

Primary Outcome Measure

Efgartigimod serum concentrations in the DBTP [ Time Frame: Up to 24 weeks ]

Central Contacts

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