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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through week 24
Awards & highlights

Study Summary

This trial will test the efficacy and safety of VX-121/tezacaftor/deutivacaftor in CF patients who have one F508del mutation and one minimal function mutation.

Who is the study for?
This trial is for people with cystic fibrosis who have one F508del mutation and another mutation that minimally functions. They should be able to breathe out at least 40% of the air in their lungs in one second, but not more than 80-90%, depending on current treatments. People with severe liver problems, certain lung infections, or those pregnant or breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests VX-121/TEZ/D-IVA's effectiveness and safety against cystic fibrosis compared to a placebo and other therapies like ELX/TEZ/IVA. Participants will randomly receive either the test drug combination or a matching placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience issues related to the digestive system, liver function changes, potential allergic reactions, respiratory symptoms worsening temporarily after treatment initiation.

Timeline

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 VX20-121-103)
Proportion of Participants With SwCl <60 Millimole per Liter (mmol/L) Through Week 24 (Pooled With Data From Study VX20-121-103)

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
Placebo (matched to IVA)
2020
Completed Phase 3
~1580
VX-121/TEZ/D-IVA
2022
Completed Phase 3
~1070
Placebo (matched to ELX/TEZ/IVA)
2020
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
241 Previous Clinical Trials
31,805 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,286 Patients Enrolled for Cystic Fibrosis

Media Library

ELX/TEZ/IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05033080 — Phase 3
Cystic Fibrosis Research Study Groups: VX-121/TEZ/D-IVA, ELX/TEZ/IVA
Cystic Fibrosis Clinical Trial 2023: ELX/TEZ/IVA Highlights & Side Effects. Trial Name: NCT05033080 — Phase 3
ELX/TEZ/IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05033080 — Phase 3

Frequently Asked Questions

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

What other research has been conducted with VX-121/TEZ/D-IVA?

"At the moment, there are 15 VX-121/TEZ/D-IVA trials in Phase 3 and 22 live studies being conducted in total. Most of these VX-121/TEZ/D-IVA trials are based in Bochum and California, but there are 1038 clinical trial sites for VX-121/TEZ/D-IVA in total."

Answered by AI

Could you please tell me how many hospitals are participating in this research project?

"There are a total of 69 sites running this clinical trial, with convenient locations in Cleveland, Toledo, and Lexington. By enrolling at the location closest to you, you can help minimize travel demands."

Answered by AI

Could you please give an estimate of the total amount of people who have agreed to participate in this clinical trial?

"The sponsor, Vertex Pharmaceuticals Incorporated, needs to recruit 400 patients that meet the eligibility for the study from multiple sites. These sites include Cleveland Clinic CF in Cleveland, Ohio and ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic fibrosis Center in Toledo, Kentucky."

Answered by AI

Are there other similar trials to this one that have been conducted in the past?

"There are 22 ongoing clinical trials for VX-121/TEZ/D-IVA in 23 countries and 110 cities. The first trial was sponsored by Vertex Pharmaceuticals Incorporated and completed its Phase 3 in 2015. A total of 1044 patients were involved. 86 clinical trials have been conducted since then."

Answered by AI

Does VX-121/TEZ/D-IVA have FDA approval for therapeutic use?

"VX-121/TEZ/D-IVA's safety is supported by clinical data, making it a 3 on our 1-3 scale."

Answered by AI

What are the VX-121/TEZ/D-IVA treatments commonly used to target?

"VX-121/TEZ/D-IVA is most commonly used to treat patients that have the homozygous for f508del mutation in the cftr gene. However, it has also been used to ameliorate symptoms in cystic fibrosis (cf), cystic fibrosis, homozygous for the f508del cftr mutation, and ivacaftor-responsive cftr mutation patients."

Answered by AI

Are patients being recruited for this trial at this time?

"The correct, as detailed on clinicaltrials.gov, this research is actively recruiting patients. The original posting date was September 14th, 2021 and the most recent update was October 10th, 2022. 400 individuals are needed for the research to be conducted across 69 sites."

Answered by AI
~125 spots leftby Mar 2025