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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 day 1 up to week 28

Awards & highlights

Study Summary

This trial will study a new drug for CF in patients 6 and up with a specific CFTR mutation.

Eligible Conditions

Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 28 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 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

Secondary outcome measures

Absolute Change in Body Mass Index (BMI)

Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain (RD) Score

Absolute Change in Sweat Chloride (SwCl)

+3 more

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ELX/TEZ/IVAExperimental Treatment2 Interventions

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

Group II: PlaceboPlacebo Group2 Interventions

Participants will receive placebo matched to ELX/TEZ/IVA in the morning and placebo matched to 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

32,080 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,442 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

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

Are there any open enrollments left for this research program?

"That is correct. As indicated by the information available on clinicaltrials.gov, this trial is still recruiting patients. The 270 participants will be drawn from 5 different locations, and the study was originally posted on May 9th, 2022."

Answered by AI

Is ELX/TEZ/IVA more harmful than other treatments?

"ELX/TEZ/IVA is in Phase 3 trials, which means that while there is some evidence of efficacy, more data is needed to support safety. Our team at Power rates the safety of ELX/TEZ/IVA as a 3."

Answered by AI

How many people are currently signed up for this research project?

"Yes, this is an ongoing trial that is currently seeking patients. The trial's listing on clinicaltrials.gov shows that it was first posted on May 9th, 2022 and was last edited on October 21st, 2022. There are 5 sites enrolling patients and the goal is to have 270 participants total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation

2022. "Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05274269.