A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Purpose

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Condition

  • Cystic Fibrosis

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study - Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A

Exclusion Criteria

  • History of drug intolerance in a parent study - Pregnant or breast-feeding females at the time of enrollment in Part A Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VX-121/TEZ/D-IVA 		Part A: Participants will receive VX-121/TEZ/D-IVA once daily for 96 weeks. Part B: Participants will receive VX-121/TEZ/D-IVA once daily for an additional 48 weeks.
  • Drug: VX-121/TEZ/D-IVA
    Fixed-dose combination tablets for oral administration.
    Other names:
    • VX-121/VX-661/CTP-656
    • VX-121/VX-661/VX-561
    • VX-121/tezacaftor/deutivacaftor

Recruiting Locations

More Details

NCT ID
NCT05444257
Status
Active, not recruiting
Sponsor
Vertex Pharmaceuticals Incorporated