ADAPT Forward 1 - ISA1 - 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
argenx · NCT07284420
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 70
- US sites recruiting
- 14
- Study start
- December 19, 2025
- Record last updated
- September 24, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: Efgartigimod IV; Empasiprubart IV
Conditions: AChR-Ab Seropositive Generalized Myasthenia Gravis; Myasthenia Gravis; MG; gMG; Generalized Myasthenia Gravis; Generalized Myasthenia Gravis (gMG)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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)
Recruiting US locations
Profound Research LLC - Carlsbad
Carlsbad, CA 92011
Site contact: Gregory Sahagian, MD · 760-732-0557 · greg@profoundresearch.com
Visionary Investigators Network
Miami, FL 33176
Site contact: Andrew Lerman, MD · 786-655-8010 · alerman@fcneurology.net
University of South Florida
Tampa, FL 33620
Site contact: Tuan Vu, MD · 813-974-9413 · tvu6@usf.edu
Massachusetts General Hospital
Boston, MA 02114-2621
Site contact: Amanda Guidon, MD · 617-726-3642 · aguidon@mgb.org
Henry Ford Health Systems
Detroit, MI 48202-2608
Site contact: Kavita Grover, MD · 313-916-1906 · kgrover1@hfhs.org
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, NV 89106
Site contact: Paul Janda, MD · +1 857-350-4834 · Paul.Janda@profoundresearch.com
Dent Neurologic Institute - Amherst
Amherst, NY 14226
Site contact: Luisa Rojas Estupinan, MD · 716-250-2000 · aemborsky@dentinstitute.com
University of North Caroline at Chapel Hill-170 Manning Dr
Chapel Hill, NC 27514-4221
Site contact: James Howard, MD · +1 857-350-4834 · howardj@neurology.unc.edu
Duke Early Phase Clinical Research Unit - PPDS
Durham, NC 27710-0001
Site contact: Vern Juel, MD · 919-668-6326 · vern.juel@duke.edu
University of Cincinnati Medical Center - Goodman St
Cincinnati, OH 45219=2364
Site contact: Hani Kushlaf · (513) 558-0269 · kushlaha@ucmail.uc.edu
Ohio State Martha Morehouse Outpatient Care
Columbus, OH 43221-3502
Site contact: Miriam Freimer, MD · 614-293-4969 · Miriam.Freimer@osumc.edu
Erlanger Health System
Chattanooga, TN 37403
Site contact: Joshua Alpers, MD · 423-778-3900 · joshua.alpers@erlanger.org
National Neuromuscular Research Institute
Austin, TX 78756
Site contact: Yessar Hussain, MD · 512-920-0140 · marisol@austinneuromuscle.com
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, TX 78229
Site contact: Ratna Bhavaraju-Sanka, MD · 210-567-8229 · BhavarajuSan@uthscsa.edu
Study contacts (from the official record)
- Sabine Coppieters, MD · 857-350-4834 · clinicaltrials@argenx.com