A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 With a Parallel Optional Maximal Use Arm- in Treatment of RXLI or ARCI Ichthyosis in Subjects Aged >6
Latest Information Update: 23 Aug 2024
At a glance
- Drugs Isotretinoin (Primary) ; Isotretinoin (Primary)
- Indications Congenital ichthyosiform erythroderma
- Focus Registrational; Therapeutic Use
- Acronyms ASCEND
- Sponsors LEO Pharma; Trex Wind-down
- 21 Aug 2024 Primary endpoint (Change in Investigator global assessment (IGA) score) has not been met, according to a LEO Pharma Media Release.
- 21 Aug 2024 According to a LEO Pharma Media Release, trial results do not support submission of a New Drug Application to the US FDA.
- 21 Aug 2024 According to a LEO Pharma Media Release, detailed results are planned to be submitted for scientific publication at a later date.