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NCT Number: NCT07294170

ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

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.

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Key information

Conditions

Myasthenia Gravis AChR-Ab Seropositive Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Generalized Myasthenia Gravis Generalized Myasthenia Gravis (gMG) Immune System Diseases 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

Observational

Primary location

UZ Leuven - PPDS, Leuven, Belgium

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About this study

This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs).

The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration.

Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study:

  • NCT07284420 - ADAPT Forward 1 - 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 (https://www.clinicaltrials.gov/study/NCT07284420)
  • NCT07673627 - Adapt Forward 2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (https://clinicaltrials.gov/study/NCT07673627)

More information can be found here: https://clinicaltrials.argenx.com/adaptforward

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is at least 18 years of age and the local legal age of consent for clinical studies
  • Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment
  • If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening

Exclusion criteria

  • Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk
  • Is MGFA (Myasthenia Gravis Foundation of America) Class V

Treatment and study plan

efgartigimod IV

Biological

Intravenous infusion of efgartigimod

Empasiprubart IV

Biological

Intravenous infusion of empasiprubart

Placebo IV

Other

Intravenous infusion of placebo

Efgartigimod PH20 SC PFS

Biological

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

Primary outcomes

  1. To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes

    Time frame: Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)

Secondary outcomes

  1. To evaluate the efficacy of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes

    Time frame: Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)

    Each ISA record will specify the correct scale and time point

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

A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2025
Registry last updated
Jul 30, 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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