ReALiSe // 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

Topic / Pathology

  • SLA
  • Phase 2a

Objectives

Find out more: https://clinicaltrials.gov/study/NCT06441682

Sponsor

ARGENX

Investigator

French coordinator: Prof Philippe Corcia

Critères d'inclusion

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

Critères de non-inclusion

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

Status

Follow-Up (recruiting ended)

Participating centers

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Updated on 23 September 2025