Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
← catalyst calendarSponsored by Sionna Therapeutics Inc. (industry) · SION — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
16estimated
Sites
13
Countries
Australia, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-11-03 | actual | When the study began enrolling |
| Primary completion | Jul 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Cystic Fibrosis (CF)
Interventions
- Drug: SION-719
- Drug: Placebo-to-match SION-719
Primary outcome
what the primary-completion date above is the date OFTo 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 Day 1 through day 57
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