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

Study acronym: Advance Jr

StatusRecruiting

PhasePhase 2/3

Sponsorargenx

Started2025-10-20

View on ClinicalTrials.gov ↗

Amendment history

2026-08-11

Study Status, Contacts/Locations v10

Study sites20→21

2026-07-08

Study Identification, Study Status, Contacts/Locations v9

Trial sites expanded: 10 → 20 locations

2026-06-11

Study Status, Contacts/Locations v8

Study sites9→10

2026-06-02

Study Status, Contacts/Locations v7

Study sitesdetails revised at 1 of 9 sites

2026-05-27

Study Status, Contacts/Locations v6

Study sites8→9

Show 5 earlier versions

2026-04-17

Study Status, Contacts/Locations v5

Study sitesdetails revised at 7 of 8 sites

2026-03-04

Study Status, Study Description, Contacts/Locations, References v4

Study sites7→8

2026-02-06

Study Status, Contacts/Locations v3

Study sites5→7

2026-01-07

Study Status, Contacts/Locations v2

Study sites3→5

2025-11-20

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Primary completion date2028-03→2028-10

Completion date2030-03→2030-10

Start dateestimated 2025-09-29→confirmed 2025-10-20

Study sites0→3

2025-09-19

Original filing

Argenx

56 trials monitored

See 2 trials at risk

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

Trial Details

NCT Number	NCT07194850
Lead Sponsor	argenx
Conditions	Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia, ITP, Immune Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura ( ITP ), Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura (ITP)
Enrollment	24 participants
Start Date	2025-10-20
Primary Completion	2028-10 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-09-24