VX-121/TEZ/D-IVA for Cystic Fibrosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cystic FibrosisVX-121/TEZ/D-IVA - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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: Drug
Treatment
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

Mark “Yes” if the following statements are true for you: