NCT06441682CompletedPhase 2
A safety and efficacy study of ARGX-119 in adult patients with Amyotrophic Lateral Sclerosis (ALS) (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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Mar 2026
Brief summary (registry, in English)
To evaluate the safety and tolerability of ARGX-119 in participants with ALS
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 7 Jun 2024
- Start date
- 23 Oct 2024
- Lead sponsor
- Argenx
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06441682
- EU CT number
- 2024-511318-19-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 49
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any history of or current exposure to any gene or cell therapies (off-label use or investigational) for ALS
Other
- Use of noninvasive ventilation more than 10 hours a day or use of a tracheostomy for ventilatory support
- Pregnant or lactating state or intention to become pregnant during the study
Who the study is looking for
- 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
- SVC of ≥ 60% of the predicted value according to Global Lung Function Initiative 2012
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Completed |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Completed |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Region Stockholm – SLSO Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.