This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (PD), immunogenicity, and efficacy of subcutaneous (SC) ALXN1830 in adults with generalized myasthenia gravis (gMG).
Participants have the option to enroll in an Open-label Extension (OLE) Period to receive ALXN1830 up to 58 weeks (including follow-up period).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Clinical Study Site
Phoenix, Arizona, United States
Adverse Events (AEs) And Serious Adverse Events (SAEs) Up To Week 24
Time frame: Up to Week 24
AEs And SAEs Up To Week 82
Time frame: Up to Week 82 (OLE)
Change From Baseline In Serum Total Immunoglobulin G (IgG)
Time frame: Up to Week 24
Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score
Time frame: Up to Week 24
Change From Baseline In Quantitative Myasthenia Gravis (QMG) Score
Time frame: Up to Week 24
Number Of Participants With At Least A 2-point Improvement In The MG-ADL Score Over 4 Consecutive Weeks
Time frame: Up to Week 24
Number Of Participants With At Least A 3-point Improvement In The QMG Score Over 4 Consecutive Weeks
Time frame: Up to Week 8
Change From Baseline In Neurological Disorders Fatigue Questionnaire (Neuro-Qol) Fatigue Score
Time frame: Up to Week 24
Serum Trough Concentrations Of ALXN1830
Time frame: Up to Week 24
Change From Baseline In IgG Subtypes
Time frame: Up to Week 24
Incidence Of Anti-drug Antibodies (ADA) And Neutralizing Antibodies (Nab) Against ALXN1830
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Time frame: Up to Week 24
Titers Of ADA And Nab Against ALXN1830
Time frame: Up to Week 24