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A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

Study acronym: advance NEXT
StatusRecruiting
PhasePhase 3
Sponsorargenx
Started2024-10-18
View on ClinicalTrials.gov ↗

Amendment history

2026-04-29
Study Status, Contacts/Locations v15
Study sitescontacts updated at 2 of 94 sites
2026-04-27
Study Status, Contacts/Locations v14
Study sitescontacts updated at 41 of 94 sites
2026-04-17
Study Status, Contacts/Locations v13
Study sitescontacts updated at 52 of 94 sites
2026-03-09
Study Status, Study Description, Contacts/Locations, References v12
Study sites93→94
2026-02-06
Study Status, Contacts/Locations v11
Study sites92→93
Show 10 earlier versions
2026-01-07
Study Status, Contacts/Locations v10
Study sites83→92
2025-12-04
Study Status, Study Design, Outcome Measures, Contacts/Locations v9
Enrollment target63→69
Study sites76→83
Secondary endpoints28 entries, revised
Incidence of AEs (including AEs of clinical interest) and SAEs Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time
2025-12-01
Study Status, Contacts/Locations v8
Study sites73→76
2025-11-03
Study Status, Oversight, Outcome Measures, Contacts/Locations v7
Study sites58→73
Secondary endpoints28 entries, revised
[...] 0^9/L and a 2-fold increase from baseline in platelet count fromat study week 5 of the DBTP ExtentIn participants receiving placebo IV in the DBTP, the extent of disease control, defined as the number of cumulative weeks with platelet counts of at least 50 × 10^9/L ProportionIn participants receiving placebo IV in the DBTP, the proportion of participants achieving a platelet counts of at least 50 × 10^9/L for at least 8 of the 12 study visits between weeks 13 and 24 of the OLTP1
Primary endpoints1 entry, revised
Extent of disease control, defined as the number of cumulative weeks during the 24-week Double-Blinded Treatment Period with platelet counts of at least 50 × 10^9/L
2025-08-14
Study Status, Contacts/Locations v6
Study sites51→58
2025-07-16
Study Status, Contacts/Locations v5
Study sites23→51
2025-05-02
Study Status, Contacts/Locations v4
Study sites7→23
2025-03-28
Study Identification, Study Status, Contacts/Locations v3
Study sites2→7
Study titlerevised
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants withWith Primary Immune Thrombocytopenia
2025-01-14
Study Identification, Study Status, Contacts/Locations v2
Study sites1→2
2024-11-19
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10→confirmed 2024-10-18
Study sites0→1
Study titlerevised
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants Withwith Primary Immune Thrombocytopenia
2024-08-05
Original filing
Argenx
56 trials monitored
See 2 trials at risk
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week 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/advancenext
Trial Details
NCT Number NCT06544499
Lead Sponsor argenx
Conditions Primary Immune Thrombocytopenia (ITP)
Enrollment 69 participants
Start Date 2024-10-18
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-01