Cystic Fibrosis (CF)Phase 2PreciSION CFNCT07108153
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
A Phase 2 study testing SION-719 in people with Cystic Fibrosis (CF), run by Sionna Therapeutics Inc. at 13 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- SION-719
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 3 Nov 2025to 25 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Johns Hopkins
Baltimore, Maryland, 21205
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University Hospital of Cleveland
Cleveland, Ohio, 44106
National Jewish Health
Denver, Colorado, 80206
New York Medical College
Hawthorne, New York, 10532
University of Iowa
Iowa City, Iowa, 52242
Columbia University
New York, New York, 10032
University of Washington
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
Australia3 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash University
Melbourne, Victoria, 3004
Gold Coast University Hospital
Southport, Queensland, 4215
About this study
Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Physician-prescribed Trikafta® in People With Cystic Fibrosis Who Are Homozygous for the F508del Mutation
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- SION-719, Placebo-to-match SION-719
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SION-719Drug
All participants receive SION-719, as specified by their treatment sequence assignment
Placebo-to-match SION-719Drug
All participants receive placebo to match SION-719, as specified by their treatment sequence assignment
| Study group | Role | What they receive |
|---|---|---|
| Crossover Treatment Sequence 1: SION-719 followed by placebo-to-match SION-719 | Experimental | Participants receive SION-719 for one treatment period, and placebo to match SION-719 for the other treatment period. All participants will remain on their physician-prescribed Trikafta as background therapy throughout the study. Receives: Drug: SION-719; Drug: Placebo-to-match SION-719 |
| Crossover Treatment Sequence 2: Placebo-to-match SION-719 followed by SION-719 | Experimental | Participants receive placebo to match SION-719 for one treatment period and SION-719 for the other treatment period. All participants will remain on their physician-prescribed Trikafta as background therapy throughout the study. Receives: Drug: SION-719; Drug: Placebo-to-match SION-719 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] when SION-719 is administered to people with cystic fibrosis (CF) who are taking a standard stable dose of physician-prescribed Trikafta
Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE), v. 5.0
Measured: Day 1 through day 57
Secondary outcomes (2)
Change from baseline in sweat chloride levels
Changes from baseline in sweat chloride levels will be analyzed with mixed model repeated measures (MMRM) methods.
Measured: Baseline to Day 15 in each treatment period
Concentration of SION-719 in plasma and change of concentration of SION-719 in plasma.
Concentrations of plasma SION-719 will be evaluated at each collected timepoint and summarized using descriptive statistics.
Measured: Day 1 through day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start3 Nov 2025
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sionna Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sionna Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108153
- Sponsor's protocol ID
- SION-719-201
- Acronym
- PreciSION CF
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-blind, Placebo-controlled Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Physician-prescribed Trikafta® in People With Cystic Fibrosis Who Are Homozygous for the F508del Mutation
- ClinicalTrials.gov ID
- NCT07108153
- Acronym / sponsor ID
- PreciSION CF / SION-719-201
- Conditions
- Cystic Fibrosis (CF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sionna Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover Treatment Sequence 1: SION-719 followed by placebo-to-match SION-719 | Experimental | Drug: SION-719, Drug: Placebo-to-match SION-719Participants receive SION-719 for one treatment period, and placebo to match SION-719 for the other treatment period. All participants will remain on their physician-prescribed Trikafta as background therapy throughout the study. |
| Crossover Treatment Sequence 2: Placebo-to-match SION-719 followed by SION-719 | Experimental | Drug: SION-719, Drug: Placebo-to-match SION-719Participants receive placebo to match SION-719 for one treatment period and SION-719 for the other treatment period. All participants will remain on their physician-prescribed Trikafta as background therapy throughout the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SION-719All participants receive SION-719, as specified by their treatment sequence assignment | Drug | Crossover Treatment Sequence 1: SION-719 followed by placebo-to-match SION-719, Crossover Treatment Sequence 2: Placebo-to-match SION-719 followed by SION-719 |
| Placebo-to-match SION-719All participants receive placebo to match SION-719, as specified by their treatment sequence assignment | Drug | Crossover Treatment Sequence 1: SION-719 followed by placebo-to-match SION-719, Crossover Treatment Sequence 2: Placebo-to-match SION-719 followed by SION-719 |
Primary outcome
To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] when SION-719 is administered to people with cystic fibrosis (CF) who are taking a standard stable dose of physician-prescribed Trikafta
Time frame: Day 1 through day 57
Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE), v. 5.0
2 secondary outcomes
Change from baseline in sweat chloride levels
Time frame: Baseline to Day 15 in each treatment period
Concentration of SION-719 in plasma and change of concentration of SION-719 in plasma.
Time frame: Day 1 through day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sionna Therapeutics Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SION-719 in people with Cystic Fibrosis (CF), run by Sionna Therapeutics Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] when SION-719 is administered to people with cystic fibrosis (CF) who are taking a standard stable dose of physician-prescribed Trikafta (time frame: Day 1 through day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.