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NCT Number: NCT06441682

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

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.

The study was terminated early following review of interim data indicating that continuation was unlikely to demonstrate a clinically meaningful treatment effect. The decision was made to minimize unnecessary participant burden. This decision is not related to safety concerns.

End-of-study and Safety-Follow-Up visits are ongoing for the participants of this trial

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARGX-119

Biological

Intravenous infusion of ARGX-119

Placebo

Other

Intravenous infusion of placebo

Primary outcomes

  1. Assessment of adverse events (AEs)

    Time frame: Up to week 96

Secondary outcomes

  1. Rate of change from baseline in electrophysiological muscle scan (MScan)-derived motor unit number (MUN)

    Time frame: Up to week 24

  2. Maximum observed serum concentration (Cmax) of ARGX-119

    Time frame: Up to week 96

  3. Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time

    Time frame: Up to week 96

  4. Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time

    Time frame: Up to week 96

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Acronym: ReALiSe

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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