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New pill combo shows promise for cystic fibrosis patients

NCT ID NCT02070744

Disease control Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a combination of two oral drugs, VX-661 and ivacaftor, in 40 adults with cystic fibrosis who have a specific genetic mutation (F508del). The goal was to see if the drugs are safe and can improve lung function over 12 weeks. Participants were randomly assigned to receive either the active drugs or a placebo. The results could lead to a new treatment option for this common CF mutation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VX-661 and ivacaftor (oral tablets)
What this could lead to
If successful, this combination could improve lung function and reduce symptoms for people with cystic fibrosis who have the F508del mutation.
What could go wrong
This is an early Phase 2 trial with only 40 participants, so results may not apply to everyone. Side effects and long-term benefits are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Start date

Mar 2014

Finished

May 2016

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Homozygous for the F508del CFTR mutation * FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height * Stable CF disease as judged by the investigator Exclusion Criteria: * History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant * Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1 of the PC Phase and Day -7 or Day 1 of the OLE Phase (whichever was applicable) * Sexually active participants of reproductive potential who are not willing to follow the contraception requirements * The participant or a close relative of the participant is the investigator or sub investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • Study site

    Birmingham, Alabama, United States

  • Study site

    Palo Alto, California, United States

  • Study site

    Stanford, California, United States

  • Study site

    Altamonte Springs, Florida, United States

  • Study site

    Miami, Florida, United States

  • Study site

    Orlando, Florida, United States

  • Study site

    Tampa, Florida, United States

  • Study site

    Boise, Idaho, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    New Brunswick, New Jersey, United States

  • Study site

    New York, New York, United States

  • Study site

    Durham, North Carolina, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Oklahoma City, Oklahoma, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

  • Study site

    Charleston, South Carolina, United States

  • Study site

    Memphis, Tennessee, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Burlington, Vermont, United States

  • Study site

    Colchester, Vermont, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Milwaukee, Wisconsin, United States

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