ALS drug trial halted: ARGX-119 fails to show promise
NCT ID NCT06441682
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tested an experimental drug called ARGX-119 in 60 adults with ALS. The goal was to see if it was safe and could help with muscle function. The trial was stopped early because early results showed it was unlikely to make a meaningful difference. No safety concerns triggered the stop, but the drug did not appear effective enough to continue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARGX-119 (an experimental biologic drug given by IV infusion)
- What this could lead to
- If it had worked, this could have pointed toward a treatment to slow muscle decline in ALS. However, the study was stopped early because it was unlikely to show a meaningful benefit.
- What could go wrong
- This trial was stopped early because early data suggested it would not help patients. The drug is still experimental, and even if safe, it may not improve muscle function or slow the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
60 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
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Aug 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus Universitets Hospital
Aarhus, 8200, Denmark
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Akademiskt specialistcentrum Karolinska Institutet
Stockholm, 113 61, Sweden
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Bispebjerg University Hospital
Copenhagen, 2400, Denmark
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CHU Bretonneau
Tours, 37000, France
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Hôpital La Pitié Salpêtrière
Paris, 75013, France
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Kaye Edmonton Clinic
Edmonton, 11400, Canada
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Montreal Neurological Institute and Hospital
Montreal, H3A 2B4, Canada
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UMC Utrecht
Utrecht, 3584 CX, Netherlands
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UZ Leuven
Leuven, 3000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a synthetic compound be safe enough to test in ALS? early trial asks
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- Can donor gut bacteria reshape the immune system in ALS?
- Spinal injection drug targets genetic cause of ALS and dementia