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New combo pill aims to boost cystic fibrosis treatment

NCT ID NCT07108153

Disease control Sponsor: Sionna Therapeutics Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests whether adding a new drug called SION-719 to the standard CF medication Trikafta is safe and helps people with cystic fibrosis who have two copies of the F508del mutation. Sixteen participants will receive either SION-719 or a placebo alongside their usual Trikafta. The main focus is on safety, but researchers will also measure changes in sweat chloride, a key marker of CFTR function.

What this could mean

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

Active substance
SION-719 (added to Trikafta)
What this could lead to
If successful, this could point toward a more effective treatment for cystic fibrosis by improving lung function and reducing symptoms when combined with existing therapy.
What could go wrong
This is a small, early-phase study with only 16 participants, so results may not apply to everyone. The main goal is safety, and it's unclear if the added drug will provide meaningful benefit.

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

15 people

The number who actually took part.

Started

Nov 2025

Finished

Jun 2026

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 to 65 years

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: * Diagnosis of CF with F508del homozygous genotype based on documented CFTR genotype laboratory report. * Adherent to physician-prescribed Trikafta, as assessed by the Investigator, for at least 3 months prior to the Screening visit, taken at the recommended dose without modifications and on the regimen described in the current prescribing information. * Stable CF disease without pulmonary exacerbation within 28 days before Baseline or acute non-CF-related illness within 14 days before Baseline. Exclusion Criteria: * Participant has clinically significant current or recurrent illness, other than CF * Participant has a history of malignancy, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of recurrence for at least 1 year.

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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 (CF)

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Columbia University

    New York, New York, 10032, United States

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Johns Hopkins

    Baltimore, Maryland, 21205, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Monash University

    Melbourne, Victoria, 3004, Australia

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • New York Medical College

    Hawthorne, New York, 10532, United States

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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