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CFTR Modulator

VX-121 Combination Therapy for Cystic Fibrosis

Phase 3
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
Must not have
Pregnant or breast-feeding females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to week 100
Awards & highlights

Summary

This trialstudies the safety and effectiveness of a drug for people with cystic fibrosis over the long-term.

Who is the study for?
This trial is for individuals with cystic fibrosis who previously participated in certain VX-121 studies and completed the treatment or visits, even if they had interruptions. It's not open to pregnant or breastfeeding women or those who couldn't tolerate the drug before.Check my eligibility
What is being tested?
The study is testing the long-term safety and effectiveness of a combination therapy called VX-121/TEZ/D-IVA designed for people with cystic fibrosis to see how well it works over an extended period.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to ensure the long-term safety and tolerability of the VX-121 combination therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed or was part of the VX20-121-102 or VX20-121-103 study without permanently stopping the study drug.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to week 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to week 100 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
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)

Side effects data

From 2023 Phase 3 trial • 435 Patients • NCT05033080
27%
Infective pulmonary exacerbation of cystic fibrosis
25%
COVID-19
23%
Cough
23%
Nasopharyngitis
13%
Headache
12%
Pyrexia
12%
Oropharyngeal pain
11%
Diarrhoea
10%
Rhinorrhoea
10%
Nasal congestion
9%
Upper respiratory tract infection
9%
Influenza
9%
Viral upper respiratory tract infection
9%
Blood creatine phosphokinase increased
9%
Fatigue
9%
Sputum increased
7%
Alanine aminotransferase increased
7%
Haemoptysis
7%
Sinus congestion
6%
Aspartate aminotransferase increased
6%
Abdominal pain upper
6%
Rash
6%
Productive cough
5%
Back pain
5%
Sinusitis
5%
Arthralgia
5%
Abdominal pain
4%
Nausea
4%
Respiratory tract infection
3%
Abdominal distension
1%
Hyperphosphatasaemia
1%
Mechanical ileus
1%
Cholestasis
1%
Cellulitis
1%
Hypersensitivity
1%
Suicidal ideation
1%
Adenocarcinoma
1%
Cerebrovascular arteriovenous malformation
1%
Distal intestinal obstruction syndrome
1%
Appendicitis
1%
Diverticulitis
1%
Blood alkaline phosphatase increased
1%
Syncope
1%
Depression
1%
Pneumonia
1%
Small intestinal obstruction
1%
Urinary tract infection
1%
Viral myocarditis
100%
80%
60%
40%
20%
0%
Study treatment Arm
VNZ/TEZ/D-IVA
ELX/TEZ/IVA

Trial Design

1Treatment groups
Experimental Treatment
Group I: VX-121/TEZ/D-IVAExperimental Treatment1 Intervention
Participants will receive VX-121/TEZ/D-IVA once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deutivacaftor
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
247 Previous Clinical Trials
31,781 Total Patients Enrolled
127 Trials studying Cystic Fibrosis
16,976 Patients Enrolled for Cystic Fibrosis

Media Library

VX-121/TEZ/D-IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05444257 — Phase 3
Cystic Fibrosis Research Study Groups: VX-121/TEZ/D-IVA
Cystic Fibrosis Clinical Trial 2023: VX-121/TEZ/D-IVA Highlights & Side Effects. Trial Name: NCT05444257 — Phase 3
VX-121/TEZ/D-IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05444257 — Phase 3
~338 spots leftby Oct 2025
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