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
PHASE2
Gender
ALL
Min Age
18 Years
Max Age
N/A
Download Date
2023-04-20
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: