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A safety and efficacy study of ARGX-119 in adult patients with Amyotrophic Lateral Sclerosis (ALS) (reALiSe)
EU CTIS ID: 2024-511318-19-00
What this study is testing
To evaluate the safety and tolerability of ARGX-119 in participants with ALS
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.