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Study identifier: NCT07287982 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Intravenous Administration of ARGX-119 in Pediatric Participants Aged 5 to Less Than 18 Years With Spinal Muscular Atrophy

Condition: Spinal Muscular Atrophy (SMA)  ·  Sponsor: argenx

PhasePhase 2
Planned participants60
Who can joinAll sexes, 5 Years to 17 Years
Healthy volunteersNo

About this study

This study aims to find the correct dose of ARGX-119 for children with SMA. The study will also look at how safe the study drug is, how well it works, how it moves through the body, and how the immune system responds to it. The study consists of a double-blinded treatment period (DBTP) where participants will either receive ARGX-119 IV or placebo IV, in addition to disease-modifying therapy (DMT) for 24 weeks. Participants who complete the DBTP will enter the open-label active-treatment extension period (ATEP) during which all participants will receive ARGX-119 IV up to 100 weeks (approximately 2 years).

This description comes directly from the study's public registry record.

Talk to the study team

Sabine Coppieters, MD  ·  857-350-4834  ·  Clinicaltrials@argenx.com

Always discuss trial participation with your own doctor first.

Locations (17)

Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
Rady Childrens HospitalSan Diego, California, United StatesNot Yet Recruiting
Stanford University Medical CenterStanford, California, United StatesNot Yet Recruiting
Connecticut Children's Medical CenterHartford, Connecticut, United StatesRecruiting
Rare Disease Research FL LLCKissimmee, Florida, United StatesRecruiting
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois, United StatesRecruiting
University of Iowa Stead Family Children's HospitalIowa City, Iowa, United StatesNot Yet Recruiting
The Johns Hopkins HospitalBaltimore, Maryland, United StatesNot Yet Recruiting
Boston Children's HospitalBoston, Massachusetts, United StatesNot Yet Recruiting
The Curators of the University of Missouri on behalf of University of Missouri Health CareColumbia, Missouri, United StatesNot Yet Recruiting
Columbia University Herbert Irving Comprehensive Cancer CenterNew York, New York, United StatesNot Yet Recruiting
Rare Disease Research NC, LLCHillsborough, North Carolina, United StatesRecruiting

+ 5 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07287982