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8110 Gatehouse Road, Falls Church, VA 22042

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)

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General Information

Age Group

Adults

Status

Recruiting

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