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

Last updated: March 18, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

ARGX-119

Placebo

Clinical Study ID

NCT06441682
ARGX-119-2303
2024-511318-19-00
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Coastcriteria

  • The participant has a Treatment Research Initiative to Cure ALS (TRICALS) riskprofile of ≥ -6.0 to < -2.0

  • Slow vital capacity (SVC) of ≥ 60% of the predicted value according to Global LungFunction Initiative 2012

Exclusion

Exclusion Criteria:

  • Use of noninvasive ventilation more than 10 hours a day or use of a tracheostomy forventilatory support

  • Any history of or current exposure to any gene or cell therapies (off-label use orinvestigational) for ALS

  • Pregnant or lactating state or intention to become pregnant during the study

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: ARGX-119
Phase: 2
Study Start date:
October 23, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Kaye Edmonton Clinic

    Edmonton, 11400
    Canada

    Active - Recruiting

  • Montreal Neurological Institute and Hospital

    Montreal, H3A 2B4
    Canada

    Active - Recruiting

  • Aarhus Universitets Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Bispebjerg University Hospital

    Kopenhagen, 2400
    Denmark

    Active - Recruiting

  • Hôpital La Pitié Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

  • CHU Bretonneau

    Tours, 37000
    France

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Akademiskt specialistcentrum Karolinska Institutet

    Stockholm, 113 61
    Sweden

    Active - Recruiting

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