ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
argenx · NCT07673627
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
- 40
- US sites recruiting
- 6
- Study start
- July 10, 2026
- Record last updated
- October 16, 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 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
Being studied: Empasiprubart IV; Placebo IV; Efgartigimod PH20 SC PFS
Conditions: AChR-Ab Seropositive Generalized Myasthenia Gravis; Myasthenia Gravis (MG); MG - 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 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.
Recruiting US locations
Neurology Center of Southern California
Carlsbad, CA 92011
Site contact: Gregory Sahagian · 760-732-0557 · greg@profoundresearch.com
Visionary Investigators Network
Miami, FL 33176-2148
Site contact: Andrew Lerman, MD · 786-655-8010 · alerman@fcneurology.net
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, NV 89106
Site contact: Paul Janda · +1 857-350-4834 · Paul.Janda@profoundresearch.com
Dent Neurologic Institute - Amherst
Amherst, NY 14226
Site contact: Luisa Rojas Estupinan, MD · 716-250-2000 · lrojas@dentinstitute.com
Erlanger Health System
Chattanooga, TN 37403-2136
Site contact: Joshua Alpers, MD · 423-778-3900 · Joshua.Alpers@erlanger.org
National Neuromuscular Research Institute
Austin, TX 78759-8402
Site contact: Yessar Hussain, MD · 512-920-0140 · yessar@austinneuromuscle.com
Study contacts (from the official record)
- Sabine Coppieters, MD · 857-350-4834 · clinicaltrials@argenx.com