← Back to Search

CFTR Modulator

ELX/TEZ/IVA 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 day 1 up to week 196

Awards & highlights

Study Summary

This trial is evaluating the long-term safety and efficacy of a drug regimen for cystic fibrosis patients.

Who is the study for?

This trial is for people aged 2 and older with cystic fibrosis who have previously participated in a related study (VX20-445-111 Part B) without permanently stopping the study drug. Those with a history of not following treatment or procedures well, or intolerance to the study drug in the previous research, cannot join.Check my eligibility

What is being tested?

The trial is looking at long-term safety and effectiveness of a combination medication (elexacaftor/tezacaftor/ivacaftor) for cystic fibrosis. It will assess how well patients tolerate this treatment over time and its impact on their condition.See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience issues related to long-term use of elexacaftor/tezacaftor/ivacaftor. These could include digestive problems, respiratory symptoms, or other reactions based on individual tolerance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to week 196

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to week 196

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to week 196 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 in Lung Clearance Index (LCI) 2.5

Absolute Change in Sweat Chloride (SwCl)

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04043806

25%

Cough

23%

Infective pulmonary exacerbation of cystic fibrosis

20%

Headache

16%

Upper respiratory tract infection

15%

Sputum increased

14%

Pyrexia

13%

Oropharyngeal pain

13%

Nasopharyngitis

11%

Nasal congestion

10%

Fatigue

10%

Viral upper respiratory tract infection

Nausea

Immunisation reaction

Alanine aminotransferase increased

Blood creatine phosphokinase increased

Haemoptysis

Rhinorrhoea

Abdominal pain

Diarrhoea

COVID-19

Sinusitis

Aspartate aminotransferase increased

Back pain

Arthralgia

Dyspnoea

Productive cough

Sinus congestion

Rash

Vomiting

Pain

Myalgia

Respiration abnormal

Pneumonia

Distal intestinal obstruction syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Part A: ELX/TEZ/IVA

Part B: ELX/TEZ/IVA

Trial Design

1Treatment groups

Experimental Treatment

Group I: ELX/TEZ/IVAExperimental Treatment2 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

IVA

2018

Completed Phase 3

~5230

ELX/TEZ/IVA

2019

Completed Phase 3

~3370

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

32,317 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,679 Patients Enrolled for Cystic Fibrosis

Media Library

ELX/TEZ/IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05153317 — Phase 3

Cystic Fibrosis Research Study Groups: ELX/TEZ/IVA

Cystic Fibrosis Clinical Trial 2023: ELX/TEZ/IVA Highlights & Side Effects. Trial Name: NCT05153317 — Phase 3

ELX/TEZ/IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153317 — Phase 3

Frequently Asked Questions

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

Can ELX/TEZ/IVA be legally administered to patients in the United States?

"ELX/TEZ/IVA's safety has been corroborated by data from previous clinical trials, so it received a score of 3."

Answered by AI

How many people are participating in this clinical trial?

"The clinical trial was not updated to reflect an active recruitment status. The original posting date was 1/17/2022 with the most recent edit on 7/21/2022. However, there are currently 432 studies actively enrolling patients with cystic fibrosis and 22 for ELX/TEZ/IVA that are looking for participants."

Answered by AI

At how many locations is this research being conducted?

"This trial has 15 different sites where it is currently being conducted, these include the Washington University School of Medicine / St. Louis Children's Hospital in Saint Louis, The Hospital for Sick Children in Toronto, and British Columbia Children's Hospital in Vancouver."

Answered by AI

Are new patients being enrolled in this experiment at present?

"No, this study is not looking for participants at the moment. The clinical trial was first posted on January 17th, 2022 but was most recently updated on July 21st, 2022. There are currently 454 other trials that are actively recruiting patients."

Answered by AI

Have there been any other studies done that looked at ELX/TEZ/IVA?

"At this time, there are 22 ELX/TEZ/IVA clinical trials underway. Of these active studies, 15 are in Phase 3. While the majority of these studies originate from Bochum and California, research is being conducted at 1038 different locations worldwide."

Answered by AI

To your knowledge, is this the only research project like it that currently exists?

"At this moment, there are 22 ELX/TEZ/IVA trials taking place in 110 cities and 23 countries. The first one started in 2015--it was sponsored by Vertex Pharmaceuticals Incorporated, 1044 patients participated, and it completed Phase 3 of the drug approval process. Since then, 85 more studies have concluded."

Answered by AI

What are the main conditions that ELX/TEZ/IVA is used to treat?

"ELX/TEZ/IVA is most commonly used to treat patients with a specific gene mutation that causes cystic fibrosis. However, it can also be taken as an intervention for other conditions related to cystic fibrosis like homozygous for the f508del cftr mutation or ivacaftor-responsive cftr mutation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older

2022. "Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153317.

All > Cystic Fibrosis