A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (32 weeks)

Clinical Trial

Offered by: Nemours Children's
Location: Orlando and Jacksonville, Fla.

Trial Name

A Phase 3, Randomized, Double-Blind, Controlled Study of the Efficacy & Safety of VX-445 (32 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 both a F508 deletion and a MF mutation (F/MF).

Who can participate?

Individuals, 12 years of age or older, who have a confirmed diagnosis of Cystic Fibrosis and have both: a F508 deletion and a MF mutation (F/MF).

What is involved?

Participation could last approximately 32 weeks. This includes a screening period that will last up to 4 weeks, a 24-week treatment period and a follow-up 4 weeks after the last dose of the Study Drug.

There will be up to nine (9) clinic visits and one (1) telephone call, including:

• Blood draws: The total amount of blood that will be taken during this study will be about 167.5mL (34 teaspoons). Total of nine (9) scheduled blood draws.
• ECGs: Total of nine (9) scheduled ECGs.
• Spirometry (PFT): Total of nine (9) scheduled PFTs.
• Sweat Chloride Tests: Total of six (6) Sweat Chloride Tests.
• Eye Exams: Up to three (3) eye exams.