A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

General Information Age Group Adults Status Active Protocol Number VX20-121-102 Background Information The purpose of this research study is to compare the effects, good or bad, of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in comparison to ELX/TEZ/IVA in subjects with cystic fibrosis. Offered At Inova Fairfax Hospital 3300 Gallows Rd. Falls Church, VA 22042 Principal Investigator Christopher King, MD Eligibility Information Key Inclusion Criteria: Heterozygous for F508del and a minimal function mutation (F/MF genotype) Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted mean for age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy; FEV1 >=40% and <=80% for participants not currently receiving ELX/TEZ/IVA * Other protocol defined Inclusion/Exclusion criteria may apply Ineligibility Information Key Exclusion Criteria: History of solid organ or hematological transplantation Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15) Lung infection with organisms associated with a more rapid decline in pulmonary status Pregnant or breast-feeding females * Other protocol defined Inclusion/Exclusion criteria may apply More Information: https://clinicaltrials.gov/ct2/show/NCT05033080 Contact Information Contact Name A. Claire Collins Contact Phone 703-776-5539 Contact Email Send Email