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CFTR Modulator

VX-121 Combo for Cystic Fibrosis

Q: Do we have a precedent for VX-121/TEZ/D-IVA's efficacy?

At the moment, there are 22 ongoing studies involving VX-121/TEZ/D-IVA, 15 of which are in Phase 3. Although a large number of the trials for VX-121/TEZ/D-IVA are taking place in Bochum and <a href="https://www.withpower.com/clinical-trials/california">California</a>, there are 1038 research centres running studies on this medication across the globe.

Q: What is VX-121/TEZ/D-IVA effective in treating?

VX-121/TEZ/D-IVA is frequently used to manage homozygous for f508del mutation in the cftr gene, but it can also help patients that suffer from conditions like <a href="https://www.withpower.com/clinical-trials/cystic-fibrosis">cystic fibrosis</a> and ivacaftor-responsive cftr mutation.

Q: Are there numerous locations in this state where this trial is taking place?

Currently, 71 participants are being recruited from a variety of locations including Winston-Salem, Jackson, and Chicago.

Q: Have other research groups looked into this before?

The research and development team at Vertex Pharmaceuticals Incorporated first began clinical trials for VX-121/TEZ/D-IVA in 2015. 86 different trials have been completed in the intervening years, with the most recent ones being conducted across 110 cities and 23 countries.

Q: What is the US government's official stance on VX-121/TEZ/D-IVA?

VX-121/TEZ/D-IVA was given a safety score of 3 by our analysts at Power. This is because it is a Phase 3 trial, so while there is some efficacy data, there is also multiple rounds of safety data.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through week 24

Awards & highlights

Study Summary

This trial is testing a new drug for CF that may help people with different CF mutations.

Who is the study for?

This trial is for people with cystic fibrosis who have specific genetic mutations. They should be able to breathe out a certain amount of air in one second, which shows their lungs are working at a minimum level. People can't join if they've had an organ transplant, certain lung infections, are pregnant or breastfeeding, or have serious liver problems.Check my eligibility

What is being tested?

The study tests VX-121/TEZ/D-IVA's effectiveness and safety compared to other treatments and placebos. Participants will either receive this new combination therapy or another treatment (ELX/TEZ/IVA) or IVA alone, depending on their mutation type.See study design

What are the potential side effects?

While the side effects aren't specified here, typical ones for CF treatments may include chest discomfort, coughing, digestive issues like upset stomachs or bowel movements changes; potential liver issues could also arise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24

Secondary outcome measures

Absolute Change From Baseline in Sweat Chloride (SwCl) Through Week 24

Proportion of Participants With SwCl <30 mmol/L Through Week 24 (Pooled With Data From Study VX20-121-102)

Proportion of Participants With SwCl <60 Millimole per Liter (mmol/L) Through Week 24 (Pooled With Data From Study VX20-121-102)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VX-121/TEZ/D-IVAExperimental Treatment3 Interventions

Participants will receive VX-121/TEZ/D-IVA in the morning.

Group II: ELX/TEZ/IVAActive Control3 Interventions

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX-121/TEZ/D-IVA

2022

Completed Phase 3

~1070

Placebo (matched to ELX/TEZ/IVA)

2020

Completed Phase 3

~1470

Placebo (matched to IVA)

2020

Completed Phase 3

~1580

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor

243 Previous Clinical Trials

31,787 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,149 Patients Enrolled for Cystic Fibrosis

Media Library

VX-121/TEZ/D-IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05076149 — Phase 3

Cystic Fibrosis Research Study Groups: ELX/TEZ/IVA, VX-121/TEZ/D-IVA

Cystic Fibrosis Clinical Trial 2023: VX-121/TEZ/D-IVA Highlights & Side Effects. Trial Name: NCT05076149 — Phase 3

VX-121/TEZ/D-IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076149 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we have a precedent for VX-121/TEZ/D-IVA's efficacy?

"At the moment, there are 22 ongoing studies involving VX-121/TEZ/D-IVA, 15 of which are in Phase 3. Although a large number of the trials for VX-121/TEZ/D-IVA are taking place in Bochum and California, there are 1038 research centres running studies on this medication across the globe."

Answered by AI

What is VX-121/TEZ/D-IVA effective in treating?

"VX-121/TEZ/D-IVA is frequently used to manage homozygous for f508del mutation in the cftr gene, but it can also help patients that suffer from conditions like cystic fibrosis and ivacaftor-responsive cftr mutation."

Answered by AI

Are there numerous locations in this state where this trial is taking place?

"Currently, 71 participants are being recruited from a variety of locations including Winston-Salem, Jackson, and Chicago."

Answered by AI

Have other research groups looked into this before?

"The research and development team at Vertex Pharmaceuticals Incorporated first began clinical trials for VX-121/TEZ/D-IVA in 2015. 86 different trials have been completed in the intervening years, with the most recent ones being conducted across 110 cities and 23 countries."

Answered by AI

What is the US government's official stance on VX-121/TEZ/D-IVA?

"VX-121/TEZ/D-IVA was given a safety score of 3 by our analysts at Power. This is because it is a Phase 3 trial, so while there is some efficacy data, there is also multiple rounds of safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

2021. "A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076149.