Clinical Trial

Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2022-04-08; most recent amendment 2026-07-20.
Status change: Enrolling by Invitation → Active, Not Recruiting 2023-08-03
Status change: Recruiting → Enrolling by Invitation 2023-03-16
Status change: Not Yet Recruiting → Recruiting 2022-12-07
Trial Details
NCT Number NCT05331183
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 297 participants
Start Date 2022-11-23
Primary Completion 2027-04-06 (estimated)
Study Completion 2027-04-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-11