New Onset Generalized Myasthenia Gravis (gMG)Phase 4ADAPT-EARLYNCT06909214
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
A Phase 4 study testing Efgartigimod PH20 SC in people with New Onset Generalized Myasthenia Gravis (gMG), run by argenx at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Onset Generalized Myasthenia Gravis (gMG)
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 18 sitesUnited States
- Study dates
- 17 Apr 2025to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Emory Brain Health Center
Atlanta, Georgia, 30329
Vita Kesner, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
EZR Research
Boca Raton, Florida, 33486
Patricio Espinosa Prado, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Erlanger Neuroscience Institute
Chattanooga, Tennessee, 37403
Joshua Alpers, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Yuebing Li, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Kavita Grover, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Center for Neurological Disorders - Greenfield
Greenfield, Wisconsin, 53228-1321
Bhupendra Khatri, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
The Queen's Medical Center - West Oahu
Honolulu, Hawaii, 96813
Jeffrey Miles, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Natalia Gonzalez Caldito, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Florida Jacksonville
Jacksonville, Florida, 32209
Michael Pulley, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037
Wali Qayoumi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Visionary Investigators Network
Miami, Florida, 33133
Andrew Lerman, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
HSHS Medical Group
O'Fallon, Illinois, 62269
Raghav Govindarajan, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of California Irvine
Orange, Florida, 92868
Ali Habib, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Medsol Clinical Research Center Inc
Port Charlotte, Florida, 33952
George Li, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Samir Macwan, M.D., Inc. (S corporation)
Rancho Mirage, California, 92270
Samir Macwan, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Central Texas Neurology Consultants - Elligo
Round Rock, Texas, 78681
Adam Horvit, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Baycare Medical Group
St. Petersburg, Florida, 33705
Michael Rosario-Prieto, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Shivkumar Bhadola, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: 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.
- Being tested
- Efgartigimod PH20 SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCBiological
Subcutaneous injection of efgartigimod PH20 SC
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Participants receiving efgartigimod PH20 SC Receives: Biological: Efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 16 weeks
Secondary outcomes (4)
Changes from baseline in MG-ADL total scores over time
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).
Measured: up to 51 weeks
Changes from baseline in MG-QOL-15r total scores over time
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).
Measured: up to 51 weeks
Proportion of participants who are administered systemic corticosteroid therapy as background add-on therapy throughout the study
Measured: up to 55 weeks
Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation
Measured: up to 55 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start17 Apr 2025
- Primary completionAug 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Onset Generalized Myasthenia Gravis (gMG)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909214
- Sponsor's protocol ID
- ARGX-113-2407
- Acronym
- ADAPT-EARLY
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06909214
- Acronym / sponsor ID
- ADAPT-EARLY / ARGX-113-2407
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod PH20 SC | Experimental | Biological: Efgartigimod PH20 SCParticipants receiving efgartigimod PH20 SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod PH20 SCSubcutaneous injection of efgartigimod PH20 SC | Biological | Efgartigimod PH20 SC |
Primary outcome
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).
4 secondary outcomes
Changes from baseline in MG-ADL total scores over time
Time frame: up to 51 weeks
Changes from baseline in MG-QOL-15r total scores over time
Time frame: 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
Incidence of adverse events, serious adverse events and adverse events leading to study drug discontinuation
Time frame: up to 55 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efgartigimod PH20 SC in people with New Onset Generalized Myasthenia Gravis (gMG), run by argenx at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.