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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

Completed study drug treatment in parent study (VX18-445-104); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to week 100

Awards & highlights

Study Summary

This trial will study the effects of a new drug for cystic fibrosis patients who have one F508del mutation and one other mutation.

Eligible Conditions

Cystic Fibrosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to week 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to week 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline 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

Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary outcome measures

Part A: Absolute Change From Parent Study Baseline in BMI Z-score

Part A: Absolute Change From Parent Study Baseline in Body Mass Index (BMI)

Part A: Absolute Change From Parent Study Baseline in Body Weight

+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

1Treatment groups

Experimental Treatment

Group I: ELX/TEZ/IVAExperimental Treatment2 Interventions

Part A: Participants received ELX (elexacaftor) 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ELX/TEZ/IVA

2019

Completed Phase 3

~3370

IVA

2018

Completed Phase 3

~5230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor

243 Previous Clinical Trials

32,136 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,498 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.

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

"ELX/TEZ/IVA is a common treatment for patients with one copy of the f508del mutation in the cftr gene. However, this medication can also be used to help people with cystic fibrosis who have either two copies of the f508del mutation or who carry an ivacaftor-responsive cftr mutation."

Answered by AI

Are there other examples in the medical literature of research using ELX/TEZ/IVA?

"ELX/TEZ/IVA was first studied in 2015 at NCT02565914. As of now, there are a combined total of 85 completed and live trials. A majority of these 22 active studies are based in Houston, Texas."

Answered by AI

Has the Food and Drug Administration cleared ELX/TEZ/IVA for use?

"ELX/TEZ/IVA Phase 3 trial data suggests that this medication is safe and effective."

Answered by AI

Will this be the first time that this particular type of trial is conducted?

"Vertex Pharmaceuticals Incorporated conducted the first clinical trial for ELX/TEZ/IVA in 2015. The study had 1044 participants and resulted in the drug receiving Phase 3 approval. In total, there are currently 22 trials underway across 110 cities and 23 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

2019. "Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04058366.