AChR-Ab Seropositive Generalized Myasthenia GravisPhase 2ADAPT Forward2NCT07673627
ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
A Phase 2 study testing Empasiprubart IV and Efgartigimod PH20 SC PFS in people with AChR-Ab Seropositive Generalized Myasthenia Gravis and Myasthenia Gravis (MG), run by argenx at 8 sites in 3 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), MG - Myasthenia Gravis
- What is being tested?
- Empasiprubart IV and Efgartigimod PH20 SC PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 10 Jul 2026to Apr 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 before ISA screening or will complete immunization at least 14 days before the first IMP administration.
Who cannot join
- Clinical diagnosis of systemic lupus erythematosus (SLE).
- Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab >2 months or ravulizumab >6 months before baseline are allowed to participate.
- Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.
- Had prior empasiprubart exposure.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States6 sites, 6 recruiting
- Recruiting
Dent Neurologic Institute - Amherst
Amherst, New York, 14226
Luisa Rojas Estupinan, MD, 716-250-2000, lrojas@dentinstitute.com
- Recruiting
National Neuromuscular Research Institute
Austin, Texas, 78759-8402
Yessar Hussain, MD, 512-920-0140, yessar@austinneuromuscle.com
- Recruiting
Neurology Center of Southern California
Carlsbad, California, 92011
Gregory Sahagian, 760-732-0557, greg@profoundresearch.com
- Recruiting
Erlanger Health System
Chattanooga, Tennessee, 37403-2136
Joshua Alpers, MD, 423-778-3900, Joshua.Alpers@erlanger.org
- Recruiting
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, Nevada, 89106
Paul Janda, +1 857-350-4834, Paul.Janda@profoundresearch.com
- Recruiting
Visionary Investigators Network
Miami, Florida, 33176-2148
Andrew Lerman, MD, 786-655-8010, alerman@fcneurology.net
Greece1 site, 1 recruiting
- Recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, 546 36
Marianthi Arnaoutoglou, +1 857-350-4834, marnaoutoglou@yahoo.com
Spain1 site, 1 recruiting
- Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, 29010
Guillermina Garcia Martin, +1 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
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 ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).
The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
More information can be found here: https://clinicaltrials.argenx.com/adaptforward2
Read the detailed description
Once the master protocol and ISA2 screening periods are completed, eligible participants will be randomized to receive empasiprubart IV or placebo in the double-blinded treatment period (DBTP). All participants will then receive open-label efgartigimod PH20 SC PFS in the safety follow-up period.
The study duration for each participant is approximately up to 45 weeks.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG), MG - Myasthenia Gravis, gMG
- Being tested
- Empasiprubart IV, Placebo IV, Efgartigimod PH20 SC PFS
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empasiprubart IVBiological
Intravenous infusions of empasiprubart
Placebo IVOther
Intravenous infusions of placebo
Efgartigimod PH20 SC PFSCombination product
Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| Empasiprubart IV | Experimental | Participants receive empasiprubart IV in the DBTP Receives: Biological: Empasiprubart IV |
| Placebo IV | Placebo comparator | Participants receive placebo IV in the DBTP Receives: Other: Placebo IV |
| Efgartigimod PH20 SC PFS | Other | Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period Receives: Combination Product: Efgartigimod PH20 SC PFS |
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 the DBTP
Measured: Up to 12 weeks
Secondary outcomes (9)
MG-ADL total score change from baseline at week 12
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 12 weeks
QMG total score change from baseline at week 12
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 12 weeks
MG-ADL total score change from baseline over time up to week 12
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 12 weeks
QMG total score change from baseline over time up to week 12
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 12 weeks
Proportion of participants reaching MSE at any point by week 12
MSE: Minimal symptom expression
Measured: Up to 12 weeks
Proportion of participants who have ≥3-point reduction in MG-ADL at week 12
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 12 weeks
Proportion of participants who have ≥5-point reduction in QMG at week 12
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 12 weeks
Proportion of participants who have a positive PASS at week 12
PASS: Patient acceptable symptom state
Measured: Up to 12 weeks
Proportion of participants who have a 50% MG-ADL total score improvement at week 12
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 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start10 Jul 2026
- Primary completionOct 2027 (estimated)
- Study completionApr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673627
- Sponsor's protocol ID
- ARGX-999-2-MG-20002
- Other IDs
- 2025-522939-33-00, 2025
- Acronym
- ADAPT Forward2
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07673627
- Acronym / sponsor ID
- ADAPT Forward2 / ARGX-999-2-MG-20002
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG), MG - Myasthenia Gravis, gMG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Jun 2026 (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 ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).
The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170
More information can be found here: https://clinicaltrials.argenx.com/adaptforward2
Detailed description
Once the master protocol and ISA2 screening periods are completed, eligible participants will be randomized to receive empasiprubart IV or placebo in the double-blinded treatment period (DBTP). All participants will then receive open-label efgartigimod PH20 SC PFS in the safety follow-up period.
The study duration for each participant is approximately up to 45 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empasiprubart IV | Experimental | Biological: Empasiprubart IVParticipants receive empasiprubart IV in the DBTP |
| Placebo IV | Placebo comparator | Other: Placebo IVParticipants receive placebo IV in the DBTP |
| Efgartigimod PH20 SC PFS | Other | Combination Product: Efgartigimod PH20 SC PFSParticipants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period |
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 before ISA screening or will complete immunization at least 14 days before the first IMP administration.
Key exclusion criteria (4 listed)
- Clinical diagnosis of systemic lupus erythematosus (SLE).
- Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab >2 months or ravulizumab >6 months before baseline are allowed to participate.
- Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.
- Had prior empasiprubart exposure.
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 |
|---|---|---|
| Empasiprubart IVIntravenous infusions of empasiprubart | Biological | Empasiprubart IV |
| Placebo IVIntravenous infusions of placebo | Other | Placebo IV |
| Efgartigimod PH20 SC PFSSubcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS) | Combination product | Efgartigimod PH20 SC PFS |
Primary outcome
Incidence of adverse events and serious adverse events in the DBTP
Time frame: Up to 12 weeks
9 secondary outcomes
MG-ADL total score change from baseline at week 12
Time frame: Up to 12 weeks
QMG total score change from baseline at week 12
Time frame: Up to 12 weeks
MG-ADL total score change from baseline over time up to week 12
Time frame: Up to 12 weeks
QMG total score change from baseline over time up to week 12
Time frame: Up to 12 weeks
Proportion of participants reaching MSE at any point by week 12
Time frame: Up to 12 weeks
Proportion of participants who have ≥3-point reduction in MG-ADL at week 12
Time frame: Up to 12 weeks
Proportion of participants who have ≥5-point reduction in QMG at week 12
Time frame: Up to 12 weeks
Proportion of participants who have a positive PASS at week 12
Time frame: Up to 12 weeks
Proportion of participants who have a 50% MG-ADL total score improvement at week 12
Time frame: Up to 12 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 16 Oct 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for AChR-Ab Seropositive Generalized Myasthenia Gravis
RecruitingObservational study
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
Myasthenia Gravis, MG
RecruitingPhase 2
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
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis
RecruitingObservational study
AXIS MG Patient Registry
Myasthenia Gravis (MG), Myasthenia Gravis, Generalized
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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empasiprubart IV and Efgartigimod PH20 SC PFS in people with AChR-Ab Seropositive Generalized Myasthenia Gravis and Myasthenia Gravis (MG), run by argenx at 8 sites in 3 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Greece, Spain. 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. Some participants in this study may receive a placebo. 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 the DBTP (time frame: Up to 12 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 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.