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NCT Number: NCT07673627

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

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

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Key information

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases MG - Myasthenia Gravis Myasthenia Gravis Myasthenia Gravis (MG) Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System gMG

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Visionary Investigators Network, Miami, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Empasiprubart IV

Biological

Intravenous infusions of empasiprubart

Placebo IV

Other

Intravenous infusions of placebo

Efgartigimod PH20 SC PFS

Combination Product

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

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

    Time frame: Up to 12 weeks

    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)

  2. QMG total score change from baseline at week 12

    Time frame: Up to 12 weeks

    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)

  3. MG-ADL total score change from baseline over time up to week 12

    Time frame: Up to 12 weeks

    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)

  4. QMG total score change from baseline over time up to week 12

    Time frame: Up to 12 weeks

    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)

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

    Time frame: Up to 12 weeks

    MSE: Minimal symptom expression

  6. Proportion of participants who have ≥3-point reduction in MG-ADL at week 12

    Time frame: Up to 12 weeks

    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).

  7. Proportion of participants who have ≥5-point reduction in QMG at week 12

    Time frame: Up to 12 weeks

    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).

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

    Time frame: Up to 12 weeks

    PASS: Patient acceptable symptom state

  9. Proportion of participants who have a 50% MG-ADL total score improvement at week 12

    Time frame: Up to 12 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study 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

Acronym: ADAPT Forward2

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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