A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 14 Feb 2019
At a glance
- Drugs Ivacaftor/tezacaftor/VX-445 (Primary) ; Ivacaftor
- Indications Cystic fibrosis
- Focus Registrational; Therapeutic Use
- Sponsors Vertex Pharmaceuticals
- 03 Dec 2018 Status changed from recruiting to active, no longer recruiting.
- 06 Sep 2018 According to a Vertex Pharmaceuticals media release, additional safety and efficacy data, including secondary endpoints followed by the completion of the study is expected in the second half of 2019.
- 06 Sep 2018 According to a Vertex Pharmaceuticals media release, based on the primary efficacy endpoint at week 4 and the 12 week safety data of this study, the company expects to submit a NDA application to the US FDA for the VX-445, tezacaftor and ivacaftor triple combination regimen in people with one F508del mutation and one minimal function mutation before mid-2019.