Phase 3 Cystic Fibrosis Trial, Completed (NCT02516410)

Phase 3 Cystic Fibrosis Trial, Completed NCT02516410 Sponsor: Vertex Pharmaceuticals Incorporated Condition: Cystic Fibrosis

Printed from Voxsanity (voxsanity.com.au) — NCT02516410 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Cystic Fibrosis

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02516410) enrolled 168 people with cystic fibrosis — 85 in the placebo group and 83 in the group receiving the combination treatment VX-661/IVA (also known as tezacaftor/ivacaftor). All 85 placebo participants completed the study, while 81 of the 83 in the treatment group did so. The trial's main focus was measuring any change in lung function over 12 weeks, specifically a breathing test called FEV1 — the amount of air a person can forcefully breathe out in one second — expressed as a percentage of what would be expected for someone of that age, sex, and height. The reported data shows that, on average, the placebo group's FEV1 percentage changed by −0.1 percentage points from their starting point, while the VX-661/IVA group's changed by +1.0 percentage point. In relative terms (that is, as a proportion of each person's own starting lung function score), the placebo group showed a 0.1% relative change and the treatment group showed a 2.1% relative change. For the secondary measures, a quality-of-life questionnaire focused on breathing symptoms (scored 0–100, where higher means fewer symptoms) showed an average change of +3.8 points in the placebo group and +5.9 points in the VX-661/IVA group. The number of lung flare-up (pulmonary exacerbation) events recorded was 23 in the placebo group and 22 in the treatment group, with both groups recording approximately 0.97–0.98 such events per year. Average body mass index (BMI, a measure of weight relative to height) changed by +0.22 kg/m² in the placebo group and +0.14 kg/m² in the treatment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 32546431) ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You have a confirmed diagnosis of cystic fibrosis (CF), shown by a specific sweat test result that measures the amount of salt (chloride) in your sweat, with a result of 60 or above.
You carry one copy of a specific CF gene change called F508del, plus a second CF gene change that is not expected to respond to the study medications being tested (your genes will be checked at your first study visit).
Your lung function test result (measuring how much air you can breathe out in one second) falls between 40% and 90% of what would normally be expected for someone your age, sex, and height.

Who may not be able to join:

You have another health condition that, in the doctor's opinion, could affect the study results or make taking the study medication unsafe for you.
You have had a respiratory infection, a lung flare-up, or any changes to your lung treatments (including antibiotics) in the 28 days before starting the study.
You have previously had a transplant of a solid organ (such as a kidney or liver) or a blood/bone marrow transplant.
You have taken part in another clinical drug study, or used an approved CF gene-targeting medication, within the past 30 days before your screening visit.
You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

, Brisban, Queensland

, Chermside,

, Herston,

, Innsbruck,

, Westmead,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT02516410

Sponsor: Vertex Pharmaceuticals Incorporated

Phase: Phase 3

Status: Completed

Condition: Cystic Fibrosis

More information: https://clinicaltrials.gov/study/NCT02516410

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have a confirmed diagnosis of cystic fibrosis (CF), shown by a specific sweat test result that measures the amount of salt (chloride) in your sweat, with a result of 60 or above.
You carry one copy of a specific CF gene change called F508del, plus a second CF gene change that is not expected to respond to the study medications being tested (your genes will be checked at your first study visit).
Your lung function test result (measuring how much air you can breathe out in one second) falls between 40% and 90% of what would normally be expected for someone your age, sex, and height.

Who may not be able to join:

You have another health condition that, in the doctor's opinion, could affect the study results or make taking the study medication unsafe for you.
You have had a respiratory infection, a lung flare-up, or any changes to your lung treatments (including antibiotics) in the 28 days before starting the study.
You have previously had a transplant of a solid organ (such as a kidney or liver) or a blood/bone marrow transplant.
You have taken part in another clinical drug study, or used an approved CF gene-targeting medication, within the past 30 days before your screening visit.
You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

Registry

ClinicalTrials.gov

Start date

1 August 2015

Est. completion

7 June 2016

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇫🇷 France 🇮🇱 Israel 🇪🇸 Spain 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov