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NCT06441682 Clinical Trial

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

Amyotrophic Lateral Sclerosis Clinical Trial

— ReALiSe  

Official title:
A Phase 2a, Double-Blinded, Randomized, Placebo-Controlled, and Active-Treatment Extension Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Participants With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06441682
Other study ID # ARGX-119-2303
Secondary ID 2024-511318-19-0
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 2, 2024
Est. completion date May 2027

Study information
Verified date May 2024
Source argenx
Contact Sabine Coppieters, MD
Phone 857-350-4834
Email clinicaltrials@argenx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ARGX-119
Intravenous infusion of ARGX-119
Other:
• Placebo
Intravenous infusion of placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
argenx

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of adverse events (AEs) Up to week 96
Secondary Rate of change from baseline in electrophysiological muscle scan (MScan)-derived motor unit number (MUN) Up to week 24
Secondary Maximum observed serum concentration (Cmax) of ARGX-119 Up to week 96
Secondary Incidence of anti-drug antibodies (ADA) against ARGX-119 in serum over time Up to week 96
Secondary Prevalence of anti-drug antibodies (ADA) against ARGX-119 in serum over time Up to week 96
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