A Safety and Efficacy Study of ARGX-119 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

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

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06441682

Acronym

ReALiSe

Enrollment

Registered

2024-06-04

Start date

2024-10-23

Completion date

2026-08-12

Last updated

2026-09-15

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

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

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.

Interventions

BIOLOGICALARGX-119

Intravenous infusion of ARGX-119

OTHERPlacebo

Intravenous infusion of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* The participant is at least 18 and ≤80 years of age * The participant is diagnosed with familial or sporadic ALS according to Gold Coast criteria * The participant has a Treatment Research Initiative to Cure ALS (TRICALS) risk profile of ≥ -6.0 to \< -2.0 * Slow vital capacity (SVC) of ≥ 60% of the predicted value according to Global Lung Function Initiative 2012

Exclusion criteria

* Use of noninvasive ventilation more than 10 hours a day or use of a tracheostomy for ventilatory support * Any history of or current exposure to any gene or cell therapies (off-label use or investigational) for ALS * Pregnant or lactating state or intention to become pregnant during the study

Design outcomes

Primary

Measure	Time frame
Assessment of adverse events (AEs)	Up to week 96

Secondary

Measure	Time frame
Rate of change from baseline in electrophysiological muscle scan (MScan)-derived motor unit number (MUN)	Up to week 24
Maximum observed serum concentration (Cmax) of ARGX-119	Up to week 96
Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time	Up to week 96
Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time	Up to week 96

Countries

Belgium, Canada, Denmark, France, Netherlands, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026