AChR-Ab Seropositive Generalized Myasthenia GravisPhase 2NCT07284420
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
A Phase 2 study testing Efgartigimod IV and Empasiprubart IV in people with AChR-Ab Seropositive Generalized Myasthenia Gravis and Myasthenia Gravis, run by argenx at 33 sites in 8 countries.
Trial summary
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG
- What is being tested?
- Efgartigimod IV and Empasiprubart IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 33 sitesin 8 countries
- Study dates
- 19 Dec 2025to 7 Mar 2028
- Phase
- Phase 2
- 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 seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
- Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
- Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration
Who cannot join
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Any known complement deficiency
- Current administration of a complement inhibitor or received zilucoplan or eculizumab <2 months or ravulizumab <6 months before the first study drug administration
- Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)
Trial locations and contacts
33 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 8 countries
United States14 sites, 14 recruiting
- Recruiting
Dent Neurologic Institute - Amherst
Amherst, New York, 14226
Luisa Rojas Estupinan, MD, 716-250-2000, aemborsky@dentinstitute.com
- Recruiting
National Neuromuscular Research Institute
Austin, Texas, 78756
Yessar Hussain, MD, 512-920-0140, marisol@austinneuromuscle.com
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
Amanda Guidon, MD, 617-726-3642, aguidon@mgb.org
- Recruiting
Profound Research LLC - Carlsbad
Carlsbad, California, 92011
Gregory Sahagian, MD, 760-732-0557, greg@profoundresearch.com
- Recruiting
University of North Caroline at Chapel Hill-170 Manning Dr
Chapel Hill, North Carolina, 27514-4221
James Howard, MD, +1 857-350-4834, howardj@neurology.unc.edu
- Recruiting
Erlanger Health System
Chattanooga, Tennessee, 37403
Joshua Alpers, MD, 423-778-3900, joshua.alpers@erlanger.org
- Recruiting
University of Cincinnati Medical Center - Goodman St
Cincinnati, Ohio, 45219=2364
Hani Kushlaf, (513) 558-0269, kushlaha@ucmail.uc.edu
- Recruiting
Ohio State Martha Morehouse Outpatient Care
Columbus, Ohio, 43221-3502
Miriam Freimer, MD, 614-293-4969, Miriam.Freimer@osumc.edu
- Recruiting
Henry Ford Health Systems
Detroit, Michigan, 48202-2608
Kavita Grover, MD, 313-916-1906, kgrover1@hfhs.org
- Recruiting
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, 27710-0001
Vern Juel, MD, 919-668-6326, vern.juel@duke.edu
- Recruiting
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, Nevada, 89106
Paul Janda, MD, +1 857-350-4834, Paul.Janda@profoundresearch.com
- Recruiting
Visionary Investigators Network
Miami, Florida, 33176
Andrew Lerman, MD, 786-655-8010, alerman@fcneurology.net
- Recruiting
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, Texas, 78229
Ratna Bhavaraju-Sanka, MD, 210-567-8229, BhavarajuSan@uthscsa.edu
- Recruiting
University of South Florida
Tampa, Florida, 33620
Tuan Vu, MD, 813-974-9413, tvu6@usf.edu
Japan5 sites, 5 recruiting
- Recruiting
General Hanamaki Hospital - Kajomachi
Hanamaki, 025-0075
Kimiaki Utsugisawa, MD, kutsugisawa@gmail.com
- Recruiting
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511
Kenzo Sakurai, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IUHW Narita Hospital
Narita, 286-8520
Hiroyuki Murai, MD, murai@iuhw.ac.jp
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-0045
Yasushi Suzuki, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Shinji Saiki, MD, +1 857-350-4834, clinicaltrials@argenx.com
Germany3 sites, 3 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Sarah Hoffmann, MD, +49 30 450 539734, sarah.hoffmann@charite.de
- Recruiting
Universitätsmedizin Göttingen
Göttingen, 37075
Jana Zschuentzsch, MD, +49551399889, j.zschuentzsch@med.uni-goettingen.de
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Axel Haarmann, MD, +4993120123595, haarmann_a@ukw.de
Italy3 sites, 3 recruiting
- Recruiting
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, 24127
Giorgia Camera, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Carlo Antozzi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AORN Antonio Cardarelli
Naples, 80131
Francesco Habetswallner, MD, francesco.habetswallner@aocardarelli.it
Poland3 sites, 3 recruiting
- Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Lukasz Rzepiński, MD, +48523401414, lukasz.rzepinski@mics.medicover.com
- Recruiting
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, 40-689
Marek Smilowski, MD, +48500282494, marek.smilowski@neurologiaslaska.pl
- Recruiting
Warszawski Uniwersytet Medyczny
Warsaw, 00-665
Anna Kostera-Pruszczyk, MD, +48 22 599 2858, anna.kostera-pruszczyk@wum.edu.pl
Greece2 sites, 2 recruiting
- Recruiting
Eginitio Hospital
Athens, 115 28
Vasiliki Zouvelou, MD, +306978000000, vzouvelu@med.uoa.gr
- Recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
Marianthi Arnaoutoglou, MD, +30 6937099722, marnaoutoglou@yahoo.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Elena Cortes Vicente, MD, ecortes@santpau.cat
- Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, 29010
Guillermina Garcia Martin, MD, +34951291135, guille.garcia.eecc@gmail.com
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven - PPDS
Leuven, 3000
Kristl Claeys, MD, +3216344278, kristl.claeys@uzleuven.be
About this study
Official title: An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.
Read more
The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
More information can be found here: https://clinicaltrials.argenx.com/adaptforward1
Read the detailed description
Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV.
Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.
The study duration for each participant is approximately up to 54 weeks.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG)
- Being tested
- Efgartigimod IV, Empasiprubart IV
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod IVBiological
Intravenous infusion of efgartigimod
Empasiprubart IVBiological
Intravenous infusion of empasiprubart
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod IV + Empasiprubart IV | Experimental | Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B Receives: Biological: Efgartigimod IV; Biological: Empasiprubart IV |
| Efgartigimod IV (part A + C) | Experimental | Participants not eligible for part B, receiving efgartigimod IV in part A and C Receives: Biological: Efgartigimod IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events in parts A and B
Measured: Up to 21 weeks
Secondary outcomes (7)
MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A
The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)
Measured: Up to 18 weeks
Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2
MSE: Minimal symptom expression
Measured: Up to 21 weeks
MG-ADL total score changes from baseline over time in part B compared with part A
The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)
Measured: Up to 21 weeks
QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A
The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)
Measured: Up to 18 weeks
QMG total score changes from baseline over time in part B compared with part A
The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)
Measured: Up to 21 weeks
Proportion of participants who have a 50% MG ADL total score improvement in part B cycles 1 and 2
The Myasthenia Gravis Activities of Daily Living (MG ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)
Measured: Up to 21 weeks
Proportion of participants who have positive PASS in part B cycles 1 and 2, and part B cycles 1 or 2
PASS: Patient acceptable symptom state
Measured: Up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start19 Dec 2025
- Primary completion7 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AChR-Ab Seropositive Generalized Myasthenia GravisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284420
- Sponsor's protocol ID
- ARGX-999-2-MG-20001
- Other IDs
- 2025-522492-28-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 24 Sep 2026
- Results posted
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
- ClinicalTrials.gov ID
- NCT07284420
- Acronym / sponsor ID
- ARGX-999-2-MG-20001
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 16 Dec 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.
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.
The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
More information can be found here: https://clinicaltrials.argenx.com/adaptforward1
Detailed description
Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV.
Participants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.
The study duration for each participant is approximately up to 54 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod IV + Empasiprubart IV | Experimental | Biological: Efgartigimod IV, Biological: Empasiprubart IVParticipants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B |
| Efgartigimod IV (part A + C) | Experimental | Biological: Efgartigimod IVParticipants not eligible for part B, receiving efgartigimod IV in part A and C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
- Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
- Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration
Key exclusion criteria (4 listed)
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Any known complement deficiency
- Current administration of a complement inhibitor or received zilucoplan or eculizumab <2 months or ravulizumab <6 months before the first study drug administration
- Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)
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 IVIntravenous infusion of efgartigimod | Biological | Efgartigimod IV (part A + C), Efgartigimod IV + Empasiprubart IV |
| Empasiprubart IVIntravenous infusion of empasiprubart | Biological | Efgartigimod IV + Empasiprubart IV |
Primary outcome
Incidence of adverse events and serious adverse events in parts A and B
Time frame: Up to 21 weeks
7 secondary outcomes
MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A
Time frame: Up to 18 weeks
Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2
Time frame: Up to 21 weeks
MG-ADL total score changes from baseline over time in part B compared with part A
Time frame: Up to 21 weeks
QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A
Time frame: Up to 18 weeks
QMG total score changes from baseline over time in part B compared with part A
Time frame: Up to 21 weeks
Proportion of participants who have a 50% MG ADL total score improvement in part B cycles 1 and 2
Time frame: Up to 21 weeks
Proportion of participants who have positive PASS in part B cycles 1 and 2, and part B cycles 1 or 2
Time frame: Up to 21 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 24 Sep 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for AChR-Ab Seropositive Generalized Myasthenia Gravis
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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.
33 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efgartigimod IV and Empasiprubart IV in people with AChR-Ab Seropositive Generalized Myasthenia Gravis and Myasthenia Gravis, run by argenx at 33 sites in 8 countries.
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 3 inclusion and 4 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 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Japan, Germany, Italy, Poland and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of adverse events and serious adverse events in parts A and B (time frame: Up to 21 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 24 Sep 2026.