A Phase 2a, Double-Blinded, Randomized, Placebo-Controlled, and Active-Treatment Extension Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Participants With Amyotrophic Lateral Sclerosis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511318-19-00

Acronym

ARGX-119-2303

Enrollment

Registered

2024-09-23

Start date

2024-10-23

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Brief summary

Assessment of adverse events (AEs), Assessment of clinical laboratory tests, ECGs and vital signs

Detailed description

Rate of change from baseline to week 24 in electrophysiological muscle scan (MScan)-derived motor unit number (MUN), ARGX-119 pharmacokinetic (PK) parameters over time, Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time, Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time

Interventions

DRUGARGX-119

DRUGPlacebo to ARGX-119 concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessment of adverse events (AEs), Assessment of clinical laboratory tests, ECGs and vital signs	—

Secondary

Measure	Time frame
Rate of change from baseline to week 24 in electrophysiological muscle scan (MScan)-derived motor unit number (MUN), ARGX-119 pharmacokinetic (PK) parameters over time, Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time, Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time	—

Countries

Belgium, Denmark, France, Netherlands, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026