A trial investigating the long-term safety and effectiveness of a new CFTR modulator combination therapy in people with CF

A Phase 3, open-label study investigating the long-term safety and effectiveness of a new triple combination therapy (VX-121, tezacaftor, and deutivacaftor) in people with CF 1-year and older (VX22-121-106)

The aim of this study is to measure the long-term safety, tolerability, and effectiveness of a combination of medicines (VX-121/TEZ/D-IVA) in people 1 year and older with CF.

The treatment is made up of three medications: VX-121, tezacaftor and deutivacaftor. Deutivacaftor is a slightly modified version of ivacaftor that is potentially more stable in the body. This means deutivacaftor can be taken once a day instead of twice a day.

People participating in the study will receive a single, daily dose of VX-121/TEZ/D-IVA in tablet form. Participants will be asked to visit the CF clinic 11 times over a period of 96 weeks, with an additional follow-up visit approximately 4 weeks after finishing the study medications. During these visits, the research team will look at how the study medications are affecting overall health and lung function. Bloods and other samples (urine, sputum) will be collected at some of the visits. Some assessments will be conducted over the telephone.

Note: Recruitment to this study is by invitation only