drugset / Trial / NCT03460990
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).
Timeline
- Start
- 2018-05-01
- Primary completion
- 2018-09-26
- Completion
- 2018-10-08
Outcome
Met primary endpoint
registry analysis (superiority test); TEZ/IVA vs VX-659/TEZ/IVA TC; p < 0.0001; Least Squares (LS) Mean Difference 10 (95% CI 7.4 to 12.5) NCT03460990 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAMOCAFTOR | Small molecule | 240 mg | Oral |
| Background | Ivacaftor | Other / unclassified | 150 mg | Oral |
| Comparator | tezacaftor | Other / unclassified | 100 mg | Oral |