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VX20-121-102: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)

Recruiting

This is a Phase 3, randomized, double-blind, ELX/TEZ/IVA-controlled, parallel-group, multicenter study to evaluate the efficacy of VX-21/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in cystic fibrosis (CF) subjects who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

I'm interested

All
12 Years and over
This study is NOT accepting healthy volunteers
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 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

Drug: VX-121/TEZ/D-IVA, Drug: ELX/TEZ/IVA, Drug: IVA, Drug: Placebo (matched to VX-121/TEZ/D-IVA), Drug: Placebo (matched to ELX/TEZ/IVA), Drug: Placebo (matched to IVA)

Cystic Fibrosis, Rare Diseases

Dean Krueger - krue0100@umn.edu
Joanne Billings
Phase 3
STUDY00013058
NCT05033080
See this study on ClinicalTrials.gov

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