← Back to Search

Potentiator

VX-445 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 a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through safety follow-up (up to 196 weeks)
Awards & highlights

Study Summary

This trial will test the safety of a new drug for cystic fibrosis patients who have one or two copies of the F508del mutation.

Eligible Conditions
  • Cystic Fibrosis

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through safety follow-up (up to 196 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through safety follow-up (up to 196 weeks) 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 subjects with adverse events (AEs) and serious adverse events (SAEs)
Secondary outcome measures
Absolute change from baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score
Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1)
Absolute change in BMI z-score
+5 more

Side effects data

From 2018 Phase 1 & 2 trial • 225 Patients • NCT03227471
24%
Cough
24%
Oropharyngeal pain
14%
Nasal congestion
14%
Sputum increased
14%
Infective pulmonary exacerbation of cystic fibrosis
10%
Nausea
10%
Sinus congestion
10%
Productive cough
10%
Upper respiratory tract infection
10%
Chest pain
10%
Paranasal sinus discomfort
5%
Diarrhoea
5%
Abdominal pain upper
5%
Headache
5%
Acne
5%
Sputum discoloured
5%
Paranasal sinus hypersecretion
5%
Sinusitis
5%
Aspartate aminotransferase increased
5%
Forced expiratory volume decreased
5%
Haemoptysis
5%
Blood bilirubin increased
5%
Blood creatine phosphokinase increased
5%
Malaise
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part F: VX-445/TEZ/VX-561 TC
Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3)
Part D: VX-445/TEZ/IVA TC - High Dose
Part D: Placebo
Part D: VX-445/TEZ/IVA TC - Low Dose
Part D: VX-445/TEZ/IVA TC - Medium Dose
Part E: TEZ/IVA
Part F: Placebo
Part E: VX-445/TEZ/IVA TC
Part A: Pooled Placebo (Except Cohort A7)
Part A: VX-445 (Except Cohort A7)
Part A: VX-445 (Cohort A7)
Part B: Pooled Placebo (Cohort B1 to B4)
Part B: VX-445 (Cohort B1 to B4)
Part C: Pooled Placebo (Cohort C1 to C3)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label Triple CombinationExperimental Treatment3 Interventions
Subjects will receive 200 mg VX-445/ 100 mg TEZ/ 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening. Parent studies are Phase 3 Vertex studies investigating VX-445 in combination with TEZ and IVA. This includes Studies VX17-445-102 and VX17-445-103.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivacaftor
FDA approved
Elexacaftor
FDA approved
Tezacaftor
FDA approved

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
31,880 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,242 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.

Is this medical trial the first of its kind?

"VX-445 has a long research history, with the first study sponsored by Vertex Pharmaceuticals Incorporated occurring in 2015. This initial trial included 1044 patients. After this successful Phase 3 drug approval, there are now 22 active trials for VX-445 taking place across 110 cities and 23 countries."

Answered by AI

What other medical research has included VX-445 in their experimental treatments?

"22 studies are ongoing that involve VX-445. Of these, 15 are Phase 3 trials. The majority of the trials for VX-445 is based in Bochum and California; however, there are 1038 total locations running this kind of study."

Answered by AI

What are VX-445's benefits in treating patients?

"VX-445 is frequently used to treat those who have the homozygous for f508del mutation in the cftr gene. It can also be effective in treating conditions like cystic fibrosis (cf), ivacaftor-responsive cftr mutation, and others that fall under the category of cystic fibrosis."

Answered by AI

What is the most recent update on VX-445's journey to FDA approval?

"VX-445 is in Phase 3 of clinical trials, so it has received a score of 3 for safety. This means that while the medication is still being tested, there is some data supporting both its efficacy and safety."

Answered by AI

Could you please tell me how many patients are included in this experiment?

"Unfortunately, patient recruitment for this study has already ceased. The trial was initially announced on October 9th, 2018 but the most recent update was on July 26th, 2022. There are presently 432 other clinical trials involving cystic fibrosis and 22 for VX-445 that are still admitting patients if you are interested in participating in research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
2018. "A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03525574.
~78 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top