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: