Clinical Trial

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

Study acronym: ADAPT-EARLY
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-03-27; most recent amendment 2026-03-09.
Status change: Not Yet Recruiting → Recruiting 2025-05-21
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