Trials Tracker

A study of the combined effects of three CFTR modulator medicines in people with cystic fibrosis aged 12 and older

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.

A study to learn more about a combination of CFTR modulator medicines in people with Cystic Fibrosis

This study is being done to learn more about a new medication called ‘VX-445’ when taken in combination with tezacaftor and ivacaftor. All three of these medications are known as CFTR modulators. CFTR modulators work to treat the underlying genetic cause of cystic fibrosis. This combination of medication is being assessed in people with Cystic Fibrosis who are 12 years and older and who are homozygous for the F508del mutation. The study will investigate how well these medications work and to check that they are safe to use. It is the hope that this combination of medications will have positive effects in some people with Cystic Fibrosis. Participants will be asked to come into the clinic at the recruitment centre 7-8 times over a 5 month period where study assessments will take place (blood tests, questionnaires, lung function etc.).

A Study of CFTR modulator combination therapy for people Heterozygous for the F508del Mutation and a Minimal Function Mutation (VX-659)

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 heterozygous for F508del and a minimal function mutation

A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis Who Have an F508del-CFTR Mutation

This is a Phase 3, OpenLabel, Rollover study to look at how safe and effective longterm treatment with VX-661 together with Ivacaftor is in paticipants aged 12 years and older with cystic fibrosis (CF) that have a F508de-lCFTR mutation. The study involves treating all participants who meet all the rules of the study from one of the parent studies (VX-661-106,108,109 or 111) with a combination of VX-661 and Ivacaftor for approximately 96 weeks with a follow-up 28 days after the last dose. Approximately 1375 participants are potentially eligible to be enrolled. There is also an observational cohort (group) that will enable participants under 18 years of age that received at least 4 weeks of the study drug in the parent study who meet the other rules of the study to enroll. These participants will not receive any study drug but they will have regularly scheduled telephone calls to assess post treatment safety of the combination of VX661/Ivacaftor.