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RecruitingNCT07673627ADAPT Forward2Updated Nov 4, 2026

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 interventional study of Empasiprubart IV and Placebo IV in AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG) and MG - Myasthenia Gravis, sponsored by argenx. Recruiting at 14 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by argenx · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Updated Nov 4, 2026First sites in 5 new countries10 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • AChR-Ab Seropositive Generalized Myasthenia Gravis
  • Myasthenia Gravis (MG)
  • MG - Myasthenia Gravis
  • gMG

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03

In context

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

This study's planned enrollment of 40 is close to the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

argenx is the lead sponsor of 87 studies on the registry; 29 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.

Browse argenx studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Empasiprubart IV

    Participants receive empasiprubart IV in the DBTP

    Biological: Empasiprubart IV

  • Placebo comparator
    Placebo IV

    Participants receive placebo IV in the DBTP

    Other: Placebo IV

  • Other
    Efgartigimod PH20 SC PFS

    Participants receive open-label efgartigimod PH20 SC PFS in the safety follow-up period

    Combination Product: Efgartigimod PH20 SC PFS

Interventions

  • BiologicalEmpasiprubart IV

    Intravenous infusions of empasiprubart

  • OtherPlacebo IV

    Intravenous infusions of placebo

  • Combination productEfgartigimod PH20 SC PFS

    Subcutaneous administration of efgartigimod PH20 via pre-filled syringe (PFS)

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events and serious adverse events in the DBTP

    Time frame: Up to 12 weeks

Secondary outcomes

  1. 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)

    Time frame: Up to 12 weeks

  2. 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)

    Time frame: Up to 12 weeks

  3. 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)

    Time frame: Up to 12 weeks

  4. 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)

    Time frame: Up to 12 weeks

  5. Proportion of participants reaching MSE at any point by week 12

    MSE: Minimal symptom expression

    Time frame: Up to 12 weeks

  6. 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).

    Time frame: Up to 12 weeks

  7. 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).

    Time frame: Up to 12 weeks

  8. Proportion of participants who have a positive PASS at week 12

    PASS: Patient acceptable symptom state

    Time frame: Up to 12 weeks

  9. 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).

    Time frame: Up to 12 weeks

07

Study locations

14 of 14 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Oct 2027, 15 months after the start.

Of 22 phase 2 interventional studies under Myasthenia Gravis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 30. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2026
First posted
Jun 29, 2026
StartActual
Jul 10, 2026
Primary completionEst.
Oct 2027
CompletionEst.
Apr 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
10 sites added — first sites in Greece, Spain, Belgium, Japan and Netherlands
Show 10 added (2 United States, 2 Greece, 2 Spain, 2 Japan, 1 Belgium, 1 Netherlands)
  • Neurology Center of Southern California · Carlsbad, United States
  • Profound Research LLC at Las Vegas Neurology Center · Las Vegas, United States
  • AHEPA University General Hospital of Thessaloniki · Thessaloniki, Greece
  • Hospital Regional Universitario de Malaga - Hospital General · Málaga, Spain
  • UZ Leuven · Leuven, Belgium
  • Eginitio Hospital · Athens, Greece
  • General Hanamaki Hospital · Hanamaki, Japan
  • National Hospital Organization Sendai Medical Center · Sendai, Japan
  • Leids Universitair Medisch Centrum · Leiden, Netherlands
  • Hospital de La Santa Creu i Sant Pau · Barcelona, Spain
across 2 updates, Oct 16, 2026 – Nov 4, 2026
Show all 2 updates
  1. Nov 4, 2026
    6 sites added — first sites in Belgium, Japan and Netherlands
    Show 6 added (2 Japan, 1 Belgium, 1 Greece, 1 Netherlands, 1 Spain)
    • UZ Leuven · Leuven, Belgium
    • Eginitio Hospital · Athens, Greece
    • General Hanamaki Hospital · Hanamaki, Japan
    • National Hospital Organization Sendai Medical Center · Sendai, Japan
    • Leids Universitair Medisch Centrum · Leiden, Netherlands
    • Hospital de La Santa Creu i Sant Pau · Barcelona, Spain
  2. Oct 16, 2026
    4 sites added — first sites in Greece and Spain
    Show 4 added (2 United States, 1 Greece, 1 Spain)
    • Neurology Center of Southern California · Carlsbad, United States
    • Profound Research LLC at Las Vegas Neurology Center · Las Vegas, United States
    • AHEPA University General Hospital of Thessaloniki · Thessaloniki, Greece
    • Hospital Regional Universitario de Malaga - Hospital General · Málaga, Spain

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07673627
Lead sponsor
argenx
Responsible party
Sponsor
First posted
Jun 29, 2026
Start date
Jul 10, 2026
Primary completion
Oct 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Sabine Coppieters, MD
Contact
clinicaltrials@argenx.com
857-350-4834

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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