A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05444257|
Recruitment Status : Enrolling by invitation
First Posted : July 5, 2022
Last Update Posted : November 8, 2023
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: VX-121/TEZ/D-IVA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis|
|Actual Study Start Date :||November 8, 2022|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||October 2025|
Participants will receive VX-121/TEZ/D-IVA once daily.
Fixed-dose combination tablets for oral administration.
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day 1 up to Week 100 ]
- Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) [ Time Frame: From Baseline up to Week 96 ]
- Absolute Change From Baseline in Sweat Chloride (SwCl) [ Time Frame: From Baseline up to Week 96 ]
- Number of Pulmonary Exacerbations (PEx) [ Time Frame: From Baseline up to Week 96 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05444257