This study aims to evaluate the safety of ARGX-119 in adults with ALS. The study will also assess the impact of ARGX-119 on ALS disease outcomes, including muscle function. The study consists of 2 periods: a treatment period when participants will receive one of three ARGX-119 doses or placebo and an extension period when all participants will receive the same dose of ARGX-119. Participation in the study will last up to approximately 100 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
UZ Leuven
Leuven, Belgium
Kaye Edmonton Clinic
Edmonton, Canada
Montreal Neurological Institute and Hospital
Montreal, Canada
Aarhus Universitets Hospital
Aarhus, Denmark
Assessment of adverse events (AEs)
Time frame: Up to week 96
Rate of change from baseline in electrophysiological muscle scan (MScan)-derived motor unit number (MUN)
Time frame: Up to week 24
Maximum observed serum concentration (Cmax) of ARGX-119
Time frame: Up to week 96
Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time
Time frame: Up to week 96
Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time
Time frame: Up to week 96
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Bispebjerg University Hospital
Copenhagen, Denmark
Hôpital La Pitié Salpêtrière
Paris, France
CHU Bretonneau
Tours, France
UMC Utrecht
Utrecht, Netherlands
Akademiskt specialistcentrum Karolinska Institutet
Stockholm, Sweden