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

Launched by ARGENX · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called ARGX-119 for adult patients with Amyotrophic Lateral Sclerosis (ALS), a serious condition that affects muscle control. The main goals of the study are to see how safe ARGX-119 is and how it might help improve muscle function and overall health in people with ALS. The trial will take place over about 100 weeks and has two main phases: first, participants will receive either one of three doses of ARGX-119 or a placebo (a dummy treatment with no active ingredient), and then everyone will get the same dose of ARGX-119 during the extension phase.

To be eligible for this study, participants need to be between 18 and 80 years old and must have a confirmed diagnosis of ALS. They should also have specific lung function results and not be using certain types of breathing support. The study is currently looking for volunteers, and it’s important to note that individuals who are pregnant, breastfeeding, or have received certain other treatments for ALS may not be able to participate. Participants can expect regular check-ups and monitoring throughout the trial to ensure their safety and to assess the treatment's effects.

Gender

ALL

Eligibility criteria

• 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