NCT07287982 (Sparkle) is a Phase 2 clinical trial of ARGX-119 IV in Spinal Muscular Atrophy (SMA), sponsored by argenx.

Who is sponsoring NCT07287982?

NCT07287982 is sponsored by argenx.

What drugs are being tested in NCT07287982?

Interventions in NCT07287982: ARGX-119 IV, Placebo IV.

What condition does NCT07287982 study?

NCT07287982 studies Spinal Muscular Atrophy (SMA).

Is NCT07287982 still recruiting?

NCT07287982 is currently recruiting now. Last updated 18 March 2026.

Last reviewed 2026-03-18 · How we verify

NCT07287982: Sparkle

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 18 March 2026

What this trial tests

Phase 2 trial testing ARGX-119 IV in Spinal Muscular Atrophy (SMA) in 60 participants. Currently enrolling.

Timeline

19 December 2025

Primary endpoint
28 May 2029

28 May 2029

Quick facts

Lead sponsor	argenx
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	19 December 2025
Primary completion	28 May 2029
Estimated completion	28 May 2029
Sites	17 locations across United States

Drugs / interventions tested

ARGX-119 IV — full drug profile →
Placebo IV — full drug profile →

Conditions studied

Spinal Muscular Atrophy (SMA) — all drugs for Spinal Muscular Atrophy (SMA) →

Sponsor

argenx — full company profile →

Who can join

Adults 5 to 17, any sex, with Spinal Muscular Atrophy (SMA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

First-in-Human Dose Selection and Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Muscle-Specific Kinase Agonist Adimanebart (ARGX-119).
Bragt TV, Kneip C, Priem S, Leng X, et al · · 2026 · PMID 42153453 · DOI 10.1002/jcph.70208

Verify or expand the search:

Other recruiting trials for Spinal Muscular Atrophy (SMA)

Currently open trials in the same condition.

NCT07488338 — HABIT-ILE + FST in Children With SMA: Preliminary Effectiveness · NA · recruiting
NCT07321977 — Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular D · NA · recruiting
NCT07265232 — Real World Clinical Effectiveness & Safety of Vesemnogene Lantuparvovec for Spinal Muscular Atrophy (SMA) in Low-middle · Phase 3 · recruiting
NCT07223489 — Diagnostic Journey, Patient Experience, and Disparities in the Treatment of Spinal Muscular Atrophy (SMA) in the MedStar · recruiting
NCT07332702 — Long Read Analysis in Spinal Muscular Atrophy - LOREASI · NA · recruiting

Other argenx trials

Trials by the same sponsor.

NCT07377396 — A Study to Assess the Safety of ARGX-124 in Healthy Volunteers · Phase 1 · recruiting
NCT07294170 — ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Particip · recruiting
NCT07284420 — ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With · Phase 2 · recruiting
NCT07091630 — A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP · Phase 3 · recruiting
NCT06968338 — A Study to Assess the Safety of ARGX-213 in Healthy Volunteers · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07287982 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by argenx
Last refreshed: 18 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07287982.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing