- The NEXUS Clinical Study in cALD
The NEXUS trial is a phase 2, open-label clinical study that has been designed to assess the efficacy and safety of leriglitazone in male pediatric patients with early stage cerebral X-linked adrenoleukodystrophy (cALD). The EMA approved the Pediatric Investigational Plan (PIP) for leriglitazone in X-ALD based on this NEXUS trial as a registration-enabling efficacy study.
The NEXUS study recruits cALD patients with first evidence of cerebral MRI lesions. All patients will be receiving leriglitazone and they will be carefully monitored for safety, changes in clinical symptoms and in cerebral MRI lesions. The study has been designed with input from both EMA and FDA, and EU and US clinical experts in X-ALD and patient advocacy groups. The study design does not interfere with the current Standard of Care and does not delay HSCT if it becomes indicated.
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 listICM, Groupe Hospitalier Pitié SalpêtrièreParisFranceUniversity Medical Center Hamburg-EppendorfHamburgGermanyKlinik für Kinder- und JugendmedizinGöttingenGermanyHospital Sant Joan de DéuBarcelonaSpain