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

Trial ID: NCT06441682

Interventional - Phase 2 - Terminated

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

• ARGX-119
• Placebo

Eligibility

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

Sponsor

argenx

Source: ClinicalTrials.gov

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