A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
ADAPT-EARLY
A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis
1 other identifier
interventional
30
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2025
Typical duration for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 3, 2025
CompletedStudy Start
First participant enrolled
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 10, 2026
March 1, 2026
1.3 years
March 27, 2025
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC
MSE (minimal symptom expression) is defined as an MG-ADL (Myasthenia Gravis Activities of Daily Living) total score of 0 or 1. The MG-ADL scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).
up to 16 weeks
Secondary Outcomes (4)
Changes from baseline in MG-ADL total scores over time
up to 51 weeks
Changes from baseline in MG-QOL-15r total scores over time
up to 51 weeks
Proportion of participants who are administered systemic corticosteroid therapy as background add-on therapy throughout the study
up to 55 weeks
Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation
up to 55 weeks
Study Arms (1)
Efgartigimod PH20 SC
EXPERIMENTALParticipants receiving efgartigimod PH20 SC
Interventions
Eligibility Criteria
You may qualify if:
- Is at least 18 years when signing the ICF
- Has been diagnosed with gMG of MGFA class II, III, or IV
- Is seropositive for AChR-Ab
- Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG
- Had onset of generalized MG signs and/or symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and/or symptoms within 24 months before screening may be enrolled in the study
- Has an MG-ADL score ≥5
You may not qualify if:
- gMG diagnosis of MGFA class I or V
- Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis
- Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Study Sites (18)
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037, United States
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, 92270, United States
EZR Research
Boca Raton, Florida, 33486, United States
University of Florida Jacksonville
Jacksonville, Florida, 32209, United States
Visionary Investigators Network
Miami, Florida, 33133, United States
University of California Irvine
Orange, Florida, 92868, United States
Medsol Clinical Research Center Inc
Port Charlotte, Florida, 33952, United States
Baycare Medical Group
St. Petersburg, Florida, 33705, United States
Emory Brain Health Center
Atlanta, Georgia, 30329, United States
The Queen's Medical Center - West Oahu
Honolulu, Hawaii, 96813, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
HSHS Medical Group
O'Fallon, Illinois, 62269, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Erlanger Neuroscience Institute
Chattanooga, Tennessee, 37403, United States
Central Texas Neurology Consultants - Elligo
Round Rock, Texas, 78681, United States
Center for Neurological Disorders - Greenfield
Greenfield, Wisconsin, 53228-1321, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 3, 2025
Study Start
April 17, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share