Back to search results

SION-719 with Trikafta for Cystic Fibrosis

This study is looking at SION-719, a new medication, when added to Trikafta for people with Cystic Fibrosis (CF). The main goal is to see how safe SION-719 is and how well your body handles it (tolerability) when you're already taking Trikafta. Researchers will also study how SION-719 moves through your body (pharmacokinetics) and what effects it has (pharmacodynamics). You might be able to join if you are between 18 and 65 years old, have CF with a specific gene change (F508del homozygous genotype), and have been taking Trikafta consistently for at least three months. This study aims to understand if SION-719 can be safely used with your current CF treatment. The study plans to enroll 16 participants, but its current recruitment status is unclear.

Study design
This is an interventional study involving 16 participants. All participants will receive SION-719 and a matching placebo, with the specific order determined by their treatment assignment.
What's involved
Participants will be monitored for treatment-related effects from Day 1 through Day 57.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability for 57 days after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07108153

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Active, Not Recruiting
PHASE2Ages 18–65InterventionalTreatment
Sionna Therapeutics Inc.
~16 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:SION-719Placebo-to-match SION-719

At a glance

Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Day 1 through day 57

Conditions

Cystic Fibrosis (CF)

Explore related trials

Cystic FibrosisCFTR Gene

Where it's being run

13 sites across 12 states
New York2
Colorado1
Iowa1
Maryland1
Massachusetts1
Missouri1
Ohio1
South Carolina1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Sionna Therapeutics Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 TrikaftaDay 1 through day 57

    Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE), v. 5.0