A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

Official title

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation

Study identification

NCT ID

NCT05076149

Recruitment status

Completed

Study type

Interventional

Phase

Phase 3

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Enrollment

597 participants

Conditions and interventions

Eligibility (public fields only)

Age range

12 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Oct 27, 2021 (Actual)

Primary completion

May 18, 2023 (Actual)

Completion

Nov 30, 2023 (Actual)

Last update posted

Jun 13, 2024

2021 – 2023

United States locations

U.S. sites

62

U.S. states

36

U.S. cities

58

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 108 non-U.S. sites.