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ALS drug trial halted: ARGX-119 fails to show promise

NCT ID NCT06441682

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Aarhus Universitets Hospital

    Aarhus, 8200, Denmark

  • Akademiskt specialistcentrum Karolinska Institutet

    Stockholm, 113 61, Sweden

  • Bispebjerg University Hospital

    Copenhagen, 2400, Denmark

  • CHU Bretonneau

    Tours, 37000, France

  • Hôpital La Pitié Salpêtrière

    Paris, 75013, France

  • Kaye Edmonton Clinic

    Edmonton, 11400, Canada

  • Montreal Neurological Institute and Hospital

    Montreal, H3A 2B4, Canada

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

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