The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
COMPLETED
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
PHASE2
ALL
18 Years
N/A
2022-01-25
N/A
DRUG
DRUG
DRUG
DRUG
VX-561
IVA
Placebo
Placebo
For more information and to contact the study team: