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NCT06460506 Clinical Trial

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older

Cystic Fibrosis Clinical Trial

Official title:
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06460506
Other study ID # VX22-445-123
Secondary ID 2023-509563-24-0
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date October 2024
Est. completion date September 2027

Study information
Verified date June 2024
Source Vertex Pharmaceuticals Incorporated
Contact Medical Information
Phone 617-341-6777
Email medicalinfo@vrtx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 2027
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 12 Months and older
Eligibility Key Inclusion Criteria: - Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study Key Exclusion Criteria: - History of drug intolerance in the parent study that would pose an additional risk to the participant - Current participation in an investigational drug trial other than the parent study Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ELX/TEZ/IVA
Fixed-dose combination granules for oral administration.
• IVA
Granules for oral administration

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Week 100
Secondary Absolute Change in Sweat Chloride (SwCl) From Baseline through Week 96
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