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Clinical Trials in Sweden / NCT05331183
Active, not recruiting Phase 3

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

NCT05331183 · tracked via the Priya Life Science Sweden tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 3
Started
2022-11-23
Last updated
2026-09-10

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

ELX/TEZ/IVA →IVA →

ELX/TEZ/IVA: Fixed-dose combination (FDC) tablets for oral administration.

IVA: Tablets for oral administration.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: Part A: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but 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 completed study visits up to the last scheduled visit of the treatment period of Part A Key Exclusion Criteria: History of study drug intolerance in the parent study Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — Day 1 up to Week 196

Trial sites (81)

FacilityCityRegionStatus
Medizinische Universität Innsbruck - Heilstättenschule Universitätsklinik Innsbruck Austria
CUB Hôpital Erasme Brussels Belgium
UZ Brussel - Campus Jette Brussels Belgium
Universitair Ziekenhuis Antwerpen (UZA) - Antwerp University Hospital Edegem Belgium
Universitair Ziekenhuis Gent Ghent Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
Universite Catholique de Louvain - Pulmonology Woluwe-Saint-Lambert Belgium
Stollery Children's Hospital Edmonton Canada
Le Centre de recherche du CHUM (CRCHUM) Montreal Canada
McGill University Health Centre, Glen Site, Montreal Children's Hospital Montreal Canada
Hospital for Sick Children - Pulmonology Toronto Canada
British Columbia Children's Hospital Vancouver Canada
St. Paul's Hospital - Pulmonology Vancouver Canada
Klinika Detskych Infekcnich Nemoci Brno Czechia
Motol University Hospital Prague Czechia
Hopital Femme Mere-Enfant Bron France
Centre Hospitalier Intercommunal Creteil - Pulmonology Créteil France
Institut Cœur Poumon, CHU de Lille Lille France
Hopital Nord Marseille France
Hopital Arnaud de Villeneuve - Service de Pneumologie et Maladies Respiratoires Montpellier France
Hôpital Nord Laennec Nantes France
CHU de Nice - Hôpital Pasteur 2 Nice France
Hopital Cochin - Pulmonology Paris France
Hopital Necker Enfants Malades - Pulmonology Paris France
Hopital Robert Debre - Pulmonology Paris France
Hôpital Lyon Sud - Pulmonology Pierre-Bénite France
Hôpital américain de Reims - Département de pédiatrie A Reims France
Hôpital Sud - Rennes Rennes France
Centre de Perharidy, Roscoff Roscoff France
Hopital Larrey Toulouse France
Hopital Bretonneau Tours France
Charité - Paediatric Pulmonology Department Berlin Germany
University Hospital Cologne (Koeln) - CF-Studienzentrum Cologne Germany
Ruhrlandklinik Essen Germany
Klinikum der Johann-Wolfgang-Goethe Universitaet - Pulmonology Frankfurt Germany
Justus-Liebig-Universität Gießen Giessen Germany
Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie Halle Germany
Medizinische Hochschule Hannover - Clinic for Pediatric Pneumology, Allergology and Neonatology, CF-Centre Hanover Germany
Medizinische Hochschule Hannover Hanover Germany
Mukoviszidose-Zentrum am Universitätsklinikum Jena Jena Germany

+ 41 more sites — see the full list on the official registry below.

More Vertex Pharmaceuticals Incorporated trials in Sweden

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Active, not recruiting
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Enrolling by invitation
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) Active, not recruiting

Other trials for the same condition

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy Active, not recruiting
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age Active, not recruiting
CFTR Modulators in Pregnancy and Postpartum Recruiting
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older Enrolling by invitation
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05331183 on ClinicalTrials.gov ↗ ← All trials in Sweden