A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (16 weeks)

Clinical Trial

Offered by: Nemours Children's
Location: Orlando

Trial Name

A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (16 weeks)

What is the trial about?

The purpose of the study is to learn more about the effectiveness and safety of VX-445 used in combination with TEZ (tezacaftor) and IVA (ivacaftor) in patients with cystic fibrosis who have two F508 deletions (F/F).

Who can participate?

Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have two F508 deletions (F/F).

What is involved?

Participation could last approximately 16 weeks. This includes a screening period that will last up to four weeks, four-week run-in period, four-week treatment period and a follow-up four weeks after the last dose of the study drug.

There will be up to seven clinic visits, including:

• Blood draws: The total amount of blood that will be taken during this study will be about 137mL (about 28 teaspoons). Total of six scheduled blood draws.
• ECGs: Total of six scheduled ECGs.
• Spirometry (PFT): Total of six scheduled PFTs.
• Sweat Chloride Tests: Total of five sweat chloride tests.
• Eye Exam: One eye exam.