A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

Study acronym: ADAPT-EARLY

StatusRecruiting

PhasePhase 4

Sponsorargenx

Started2025-04-17

View on ClinicalTrials.gov ↗

Record status

This record was last updated March 10, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-09

Study Status, Contacts/Locations v9

Study sitesdetails revised at 1 of 18 sites

2026-02-16

Study Status, Contacts/Locations v8

Study sites17→18

2026-01-07

Study Status, Contacts/Locations v7

Study sites16→17

2025-12-01

Study Status, Contacts/Locations v6

Study sites15→16

2025-11-03

Study Status, Contacts/Locations v5

Study sites12→15

Show 4 earlier versions

2025-09-30

Study Status, Contacts/Locations v4

Study sites4→12

2025-07-30

Study Status, Contacts/Locations v3

Study sites3→4

2025-06-25

Study Status, Eligibility, Contacts/Locations v2

Study sites1→3

2025-05-21

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

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-04→confirmed 2025-04-17

Study sites0→1

2025-03-27

Original filing

Argenx

56 trials monitored

See 2 trials at risk

Myasthenia Gravis

187 trials monitored

See 7 trials at risk

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Trial Details

NCT Number	NCT06909214
Lead Sponsor	argenx
Conditions	New Onset Generalized Myasthenia Gravis (gMG)
Enrollment	30 participants
Start Date	2025-04-17
Primary Completion	2026-08 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-10