NCT03912233

A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-121	Tablets for oral administration.
DRUG	TEZ	TEZ tablet for oral administration.
DRUG	VX-561	Tablets for oral administration.
DRUG	TEZ/IVA	Fixed-dose combination tablets for oral administration.
DRUG	IVA	Tablets for oral administration.
DRUG	Placebo	Placebos matched to VX-121, TEZ, and VX-561 for oral administration.

Timeline

• Start date: 2019-04-30
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2019-04-11
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

26 sites across 5 countries: United States, Germany, Netherlands, Portugal, United Kingdom

Regulatory

• FDA-regulated drug study