A study of the combined effects of three CFTR modulator medicines in people with cystic fibrosis aged 12 and older (VX18-445-113)
In order to take part in this study you will already be taking part in the VX17-659-105 study, taking VX-659 with tezacaftor and ivacaftor. For this new study, you will switch to taking VX-445 instead of VX-659. Both combinations work in the same way. VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. Your participation in this study will help us learn more about the long-term safety of VX-445 in combination with tezacaftor and ivacaftor. All three are CFTR modulators which means that they help the faulty CFTR protein to work properly.
Tezacaftor is already approved for use and is what is known as a ‘corrector’. Ivacaftor is also already approved for use and is what is known as a ‘potentiator’. VX-445 is a corrector. Everyone in the study will get the study medications.
If you meet the criteria for being in the study, you will take VX-445, tezacaftor and ivacaftor in the morning (in 2 tablets), and ivacaftor in the evening (1 tablet).
You will be asked to come into clinic around 12 times over the 22-month (nearly 2 years) participation period. During visits, the effect of the treatment will be measured with sample collection, lung function, ECG and other medical checks.
You will also receive 14 telephone calls during the participation period, each lasting around half an hour. You do not have to come to clinics for these calls.
This study is expected to recruit 400 participants worldwide.