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

March 9, 2026 updated by: argenx

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
        • Contact:
      • Rancho Mirage, California, United States, 92270
        • Recruiting
        • Samir Macwan, M.D., Inc. (S corporation)
        • Contact:
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Jacksonville
        • Contact:
      • Miami, Florida, United States, 33133
        • Recruiting
        • Visionary Investigators Network
        • Contact:
      • Orange, Florida, United States, 92868
        • Recruiting
        • University of California Irvine
        • Contact:
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Medsol Clinical Research Center Inc
        • Contact:
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • BayCare Medical Group
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience
        • Contact:
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • The Queen's Medical Center - West Oahu
        • Contact:
    • Illinois
      • O'Fallon, Illinois, United States, 62269
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • Umass Memorial Medical Center
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Erlanger Neuroscience Institute
        • Contact:
    • Texas
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Central Texas Neurology Consultants - Elligo
        • Contact:
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228-1321
        • Recruiting
        • Center for Neurological Disorders - Greenfield
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC
Biological: Efgartigimod PH20 SC
Subcutaneous injection of efgartigimod PH20 SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC
Time Frame: up to 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in MG-ADL total scores over time
Time Frame: up to 51 weeks
The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The score varies between 0 and 24 (with 24 the most severe).
up to 51 weeks
Changes from baseline in MG-QOL-15r total scores over time
Time Frame: up to 51 weeks
The MG-QoL15r (Myasthenia Gravis Quality of Life 15-item scale revised) questionnaire is a patient-reported instrument that measures the impact of MG symptoms on Quality of Life. The score varies between 0 and 30 (with 30 the lowest quality of life).
up to 51 weeks
Proportion of participants who are administered systemic corticosteroid therapy as background add-on therapy throughout the study
Time Frame: up to 55 weeks
up to 55 weeks
Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation
Time Frame: up to 55 weeks
up to 55 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-2407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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