Recruiting
Phase 2

Empasiprubart

Sponsor:

argenx

Code:

NCT07673627

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis

Myasthenia Gravis (MG)

MG - Myasthenia Gravis

gMG

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empasiprubart IV

Placebo IV

Efgartigimod PH20 SC PFS

Study Details

Brief 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

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis

Myasthenia Gravis (MG)

MG - Myasthenia Gravis

gMG

Study ID

NCT07673627

Start date

Jul 10, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empasiprubart IV

Participants receive empasiprubart IV in the DBTP

placebo comparator: Placebo IV

Participants receive placebo IV in the DBTP

other: Efgartigimod PH20 SC PFS

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

Interventions

Empasiprubart IV

Intravenous infusions of empasiprubart

Placebo IV

Intravenous infusions of placebo

Efgartigimod PH20 SC PFS

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

Primary outcome measure

  • Incidence of adverse events and serious adverse events in the DBTP [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Visionary Investigators Network

Recruiting

Miami, Florida, United States, 33176-2148

Contacts

Andrew Lerman, MD

786-655-8010alerman@fcneurology.net

Dent Neurologic Institute - Amherst

Recruiting

Amherst, New York, United States, 14226

Contacts

Luisa Rojas Estupinan, MD

716-250-2000lrojas@dentinstitute.com

Erlanger Health System

Recruiting

Chattanooga, Tennessee, United States, 37403-2136

Contacts

Joshua Alpers, MD

423-778-3900Joshua.Alpers@erlanger.org

More Information

Sponsor

argenx

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by argenx on 2026-08-21.