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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

Recruitment Status

Completed

Eligibility Criteria

Key Inclusion Criteria:

Part 1: Heterozygous for F508del and an MF mutation (F/MF)
Part 2: Homozygous for F508del (F/F)
FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height

Key Exclusion Criteria:

History of clinically significant cirrhosis with or without portal hypertension
Lung infection with organisms associated with a more rapid decline in pulmonary status
History of solid organ or hematological transplantation

Other protocol-defined Inclusion/Exclusion criteria may apply

Intervention

Intervention Type

Intervention Name

Drug

VX-121

Drug

TEZ

Drug

VX-561

Drug

TEZ/IVA

Drug

IVA

Drug

Placebo

Phase

Phase 2

Gender

All

Min Age

18 Years

Max Age

N/A

Download Date

April 20, 2023

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis NCT03912233