Current Environment:

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

Conditions

Cystic Fibrosis

Recruitment Status

Completed

Eligibility Criteria

Key Inclusion Criteria:

Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D
On ivacaftor therapy
FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height

Key Exclusion Criteria:

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

Other protocol defined Inclusion/Exclusion criteria may apply

Intervention

Intervention Type

Intervention Name

Drug

VX-561

Drug

IVA

Drug

Placebo

Drug

Placebo

Phase

Phase 2

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Download Date

January 25, 2022

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: