Recruiting

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

Sponsor:

argenx

Code:

NCT07294170

Conditions

Myasthenia Gravis

gMG

Generalized Myasthenia Gravis

Generalized Myasthenia Gravis (gMG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod IV

Empasiprubart IV

Placebo IV

Efgartigimod PH20 SC PFS

Study Details

Brief summary:

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.

Conditions

Myasthenia Gravis

gMG

Generalized Myasthenia Gravis

Generalized Myasthenia Gravis (gMG)

Study ID

NCT07294170

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

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

ISA1 participants

Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

ISA2 participants

Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis

Interventions

Efgartigimod IV

Intravenous infusion of efgartigimod

Empasiprubart IV

Intravenous infusion of empasiprubart

Placebo IV

Intravenous infusion of placebo

Efgartigimod PH20 SC PFS

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

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834 clinicaltrials@argenx.com

Locations

Profound Research LLC - Carlsbad

Recruiting

Carlsbad, California, United States, 92011

Contacts

Gregory Sahagian, MD

760-732-0557 lupe@profoundresearch.com

Visionary Investigators Network

Recruiting

Miami, Florida, United States, 33133

Contacts

Andrew Lerman, MD

786-655-8010 alerman@fcneurology.net

Visionary Investigators Network

Recruiting

Miami, Florida, United States, 33180

Contacts

Andrew Lerman, MD

857-350-4834 clinicaltrials@argenx.com

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Contacts

Tuan Vu, MD

(813) 974-9413 tvu6@usf.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114-2621

Contacts

Amanda Guidon, MD

617-726-3642 aguidon@mgb.org

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202-2608

Contacts

Kavita Grover, MD

+1 857-350-4834 clinicaltrials@argenx.com

Dent Neurologic Institute - Amherst

Recruiting

Amherst, New York, United States, 14226

Contacts

Luisa Rojas Estupinan, MD

716-250-2000 aemborsky@dentinstitute.com

Duke Early Phase Clinical Research Unit - PPDS

Recruiting

Durham, North Carolina, United States, 27710-0001

Contacts

Vern Juel, MD

+1 857-350-4834 clinicaltrials@argenx.com

Ohio State Martha Morehouse Outpatient Care

Recruiting

Columbus, Ohio, United States, 43221-3502

Contacts

Miriam Freimer, MD

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

Erlanger Health System

Recruiting

Chattanooga, Tennessee, United States, 37403-2136

Contacts

Joshua Alpers, MD

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

National Neuromuscular Research Institute

Recruiting

Austin, Texas, United States, 78759

Contacts

Yessar Hussain, MD

512-920-0140 marisol@austinneuromuscle.com

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

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Ratna Bhavaraju-Sanka, MD

210-567-8229 BhavarajuSan@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.