NCT07673627 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
| NCT ID | NCT07673627 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | argenx |
| Condition | AChR-Ab Seropositive Generalized Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-07-10 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07673627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AChR-Ab Seropositive Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07673627 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07673627 currently recruiting?
Yes, NCT07673627 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT07673627 trial being conducted?
This trial is being conducted at Miami, United States, Amherst, United States, Chattanooga, United States.
Who is sponsoring the NCT07673627 clinical trial?
NCT07673627 is sponsored by argenx. The trial plans to enroll 40 participants.