VX-20-121-102: A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)

About this Study

This study is being done to learn more about the safety and effectiveness of VX-121/TEZ/D-IVA in patients with cystic fibrosis (CF).

Sponsor Protocol ID:VX-20-121-102
IRB Number:2021-1097
Actively Enrolling
Phase 3
July 13, 2022
Eligibility Criteria
12 years old
Both Male and Female

Inclusion Criteria
  • Must be willing to comply with scheduled visits, treatment, and procedures
  • Age 12 years and older
  • Confirmed diagnosis of cystic fibrosis (CF)
  • Heterozygous for F509del and an MF mutation
  • Currently receiving ELX/TEZ/IVA
  • Stable CF diseaseĀ 
  • Willing to remain on stable CT treatment regimen through completion of study participation

Exclusion Criteria
  • Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9)
  • Solid organ or hematological transplantation
  • Alcohol or drug abuse in the past year
  • Cancer, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in site
  • History of intolerance to study drugĀ 
  • An acute upper or lower respiratory infection
  • An acute illness not related to CT within 14 days before the first dose of ELX/TEZ/IVA
  • Ongoing or prior participation in a study of an investigational treatment other than a Vertex CFTR modulator within 28 days
  • Pregnant or breast-feeding females

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Participating Locations
Cancer Center and Research Institute - UMMC
Contact Information
Contact Name: Stephanie Moore
Phone Number: 601-496-7812
Email: smoore13@umc.edu
Principal Investigator:Spurzem, John R
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