Recruiting
Phase 2

Empasiprubart & Efgartigimod

Sponsor:

argenx

Code:

NCT07284420

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis

Myasthenia Gravis

MG

gMG

Generalized Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod IV

Empasiprubart IV

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 ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.

The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

More information can be found here: https://clinicaltrials.argenx.com/adaptforward1

Conditions

AChR-Ab Seropositive Generalized Myasthenia Gravis

Myasthenia Gravis

MG

gMG

Generalized Myasthenia Gravis

Study ID

NCT07284420

Start date

Dec 19, 2025

Status verified date

Aug, 2026

Completion date

Mar 7, 2028

Anticipated

Primary completion date

Mar 7, 2028

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 of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration

Exclusion Criteria:

  • Clinical diagnosis of systemic lupus erythematosus (SLE)
  • Any known complement deficiency
  • Current administration of a complement inhibitor or received zilucoplan or eculizumab <2 months or ravulizumab <6 months before the first study drug administration
  • Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Efgartigimod IV + Empasiprubart IV

Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B

experimental: Efgartigimod IV (part A + C)

Participants not eligible for part B, receiving efgartigimod IV in part A and C

Interventions

Efgartigimod IV

Intravenous infusion of efgartigimod

Empasiprubart IV

Intravenous infusion of empasiprubart

Primary outcome measure

  • Incidence of adverse events and serious adverse events in parts A and B [ Time Frame: Up to 21 weeks ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834clinicaltrials@argenx.com

Locations

Profound Research LLC - Carlsbad

Recruiting

Carlsbad, California, United States, 92011

Contacts

Gregory Sahagian, MD

760-732-0557greg@profoundresearch.com

Visionary Investigators Network

Recruiting

Miami, Florida, United States, 33176

Contacts

Andrew Lerman, MD

786-655-8010alerman@fcneurology.net

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Contacts

Tuan Vu, MD

813-974-9413tvu6@usf.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114-2621

Contacts

Amanda Guidon, MD

617-726-3642aguidon@mgb.org

Henry Ford Health Systems

Recruiting

Detroit, Michigan, United States, 48202-2608

Contacts

Kavita Grover, MD

313-916-1906kgrover1@hfhs.org

Dent Neurologic Institute - Amherst

Recruiting

Amherst, New York, United States, 14226

Contacts

Luisa Rojas Estupinan, MD

716-250-2000aemborsky@dentinstitute.com

Duke Early Phase Clinical Research Unit - PPDS

Recruiting

Durham, North Carolina, United States, 27710-0001

Contacts

Vern Juel, MD

919-668-6326vern.juel@duke.edu

Ohio State Martha Morehouse Outpatient Care

Recruiting

Columbus, Ohio, United States, 43221-3502

Contacts

Miriam Freimer, MD

614-293-4969Miriam.Freimer@osumc.edu

Erlanger Health System

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Joshua Alpers, MD

423-778-3900joshua.alpers@erlanger.org

National Neuromuscular Research Institute

Recruiting

Austin, Texas, United States, 78756

Contacts

Yessar Hussain, MD

512-920-0140marisol@austinneuromuscle.com

University of Texas- San Antonio - Health Science Center - PPDS

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Ratna Bhavaraju-Sanka, MD

210-567-8229BhavarajuSan@uthscsa.edu

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.