ADAPT ISA2 · ARGX-999-2-MG-20002

Exploratory research evaluating the use of intravenous empasiprubart in patients with generalized myasthenia gravis who are seropositive for anti-AChR antibodies, focusing on its safety, tolerability, and therapeutic response.

ISA2 under the ARGX-999-2-MG-2000 Master Protocol: A phase 2a, randomized, double-blind, placebo-controlled exploratory study evaluating the safety, tolerability, and efficacy of intravenous empasiprubart monotherapy in participants with generalized myasthenia gravis who are seropositive for anti-AChR antibodies.

Sponsor: argenx BV

Phase: II

Status: Recruiting

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Public study eligibility criteria

Inclusion

  • MP Main inclusion criteria: o Is at least 18 years of age and the local legal age of consent for clinical studies o Has been diagnosed with MG consistent with MG's clinical features and with symptom severity appropriate for currently enrolling ISAs, per the investigator’s clinical judgment o 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
  • ISA 2- - 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

  • MP Main exclusion criteria: o 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. o Is MGFA (Myasthenia Gravis Foundation of America) Class V
  • ISA 2- - 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