Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04812925 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Study acronym: ADVANCE SC+
StatusActive, Not Recruiting
PhasePhase 3
Sponsorargenx
Started2021-11-17
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 23, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-01-09
Study Identification, Study Status, Oversight v17
Study titlerevised
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients withWith Primary Immune Thrombocytopenia
2024-12-02
Study Identification, Study Status, Oversight v16
Study titlerevised
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients Withwith Primary Immune Thrombocytopenia
2023-11-09
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 156→confirmed 173
Study sitesdetails revised at 83 of 83 sites
2023-08-25
Study Status, Contacts/Locations v14
Study sites80→83
2023-07-28
Study Status, Contacts/Locations v13
Study sites75→80
Show 12 earlier versions
2023-06-30
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 75 sites
2023-06-14
Study Status, Contacts/Locations v11
Study sites74→75
2023-05-16
Study Status, Eligibility, Contacts/Locations v10
Study sites72→74
Eligibility criteria-99 characters
[...] ree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical trials and the following: Male• participants. Female participants of childbearing potential must have a ne [...]
2023-04-07
Study Status, Contacts/Locations v9
Study sites71→72
2023-01-31
Study Status, Contacts/Locations v8
Study sites37→71
2022-06-27
Study Status, Contacts/Locations v7
Study sites16→37
2022-05-03
Study Status, Eligibility, Contacts/Locations v6
Study sites10→16
Eligibility criteria-422 characters
[...] participant has had an SAE during the ARGX-113-2004 trial, his/hertheir eligibility should be evaluated by the investigator and the [...] f enrolling the participant will be evaluated case by case. Women3a. Agree to use contraceptives consistent with local regulations regarding the methods of childbearingcontraception potential:for •those As definedparticipating in Womanclinical oftrials Childbearing Potential inand the protocol,following: Male womenparticipants. Female participants of childbearing potential must have a negative urine pregnancy test at baseline before trialreceiving medication can b [...] [...]
2022-04-04
Study Status, Contacts/Locations v5
Study sites5→10
2022-03-04
Study Status, Contacts/Locations v4
Study sites3→5
2022-01-13
Study Status, Contacts/Locations v3
Study sites1→3
2021-12-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-11-01→confirmed 2021-11-17
Study sites0→1
2021-06-30
Study Status v1
Start date2021-06-01→2021-11-01
2021-03-19
Original filing
Argenx
56 trials monitored
See 2 trials at risk
A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia
Trial Details
NCT Number NCT04812925
Lead Sponsor argenx
Conditions Primary Immune Thrombocytopenia
Enrollment 173 participants
Start Date 2021-11-17
Primary Completion 2026-10-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-23