The NEXUS Clinical Study in cALD
- The NEXUS Clinical Study in cALD
NEXUS is a completed 96-week, pivotal, open-label, multicenter study (NEXUS; NCT04528706) of once-daily oral leriglitazone in pediatric patients with cALD. NEXUS enrolled 23 patients and the evaluable population consisted of those patients treated for a minimum of 24 weeks (n=20).
The primary endpoint assessed the proportion of evaluable patients that have clinically and radiologically arrested disease at week 96 or at a visit prior to HSCT (success criteria: one-sided 95% [CI] > 10%). Secondary endpoints include change from baseline in NFS and Loes score (LS). Change from baseline in lesion volume and plasma biomarker concentrations are exploratory endpoints. The study concluded in December 2024 and the primary endpoint was met.
For further information visit:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-000654-59Hospitals involved in NEXUS Clinical StudySee mapICM, Groupe Hospitalier Pitié SalpêtrièreParisFranceUniversity Medical Center Hamburg-EppendorfHamburgGermanyKlinik für Kinder- und JugendmedizinGöttingenGermanyHospital Sant Joan de DéuBarcelonaSpainHospitals involved in NEXUS Clinical StudySee list
ICM, Groupe Hospitalier Pitié SalpêtrièreParisFranceUniversity Medical Center Hamburg-EppendorfHamburgGermanyKlinik für Kinder- und JugendmedizinGöttingenGermanyHospital Sant Joan de DéuBarcelonaSpain
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