Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06441682 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ReALiSe
StatusTerminated
PhasePhase 2
Sponsorargenx
Started2024-10-23
View on ClinicalTrials.gov ↗
Why the trial stopped
The study was terminated 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 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.

Amendment history 1 change detected by DataLookout

2026-09-16
Trial terminated: The study was terminated following review of interim data indicating that continuation was unlikely to demonstrate a cl...
Trial Details
NCT Number NCT06441682
Lead Sponsor argenx
Conditions Amyotrophic Lateral Sclerosis
Enrollment 60 participants
Start Date 2024-10-23
Primary Completion 2026-08-12 (estimated)
Study Completion 2026-08-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-15