Study Summary
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.
Eligible Conditions
- Cystic Fibrosis
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: From Day 1 up to Week 100
Week 96
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Absolute Change From Baseline in Sweat Chloride (SwCl)
Number of Pulmonary Exacerbations (PEx)
Week 100
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
VX-121/TEZ/D-IVA
1 of 1
Experimental Treatment
850 Total Participants · 1 Treatment Group
Primary Treatment: VX-121/TEZ/D-IVA · No Placebo Group · Phase 3
VX-121/TEZ/D-IVA
Drug
Experimental Group · 1 Intervention: VX-121/TEZ/D-IVA · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-121/TEZ/D-IVA
2022
Completed Phase 1
~20
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 up to week 100
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
221 Previous Clinical Trials
29,720 Total Patients Enrolled
118 Trials studying Cystic Fibrosis
16,210 Patients Enrolled for Cystic Fibrosis
Eligibility Criteria
Age Any Age · All Participants · 2 Total Inclusion Criteria
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Conditions
Cancer Related
Treatments