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SION-719

Phase 2

Cystic Fibrosis (CF) | Small molecule | Respiratory |Sionna Therapeutics, Inc.|Last Updated: May 6, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical trial landscape

SION-719 · 1 trial · 1 indication

Phase 2 1
NCT07108153Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to TrikaftaCystic Fibrosis (CF)
ACTIVE NOT_RECRUITING16 Analytics
PHASE2ACTIVE NOT_RECRUITING
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
Cystic Fibrosis (CF)
NCT0710815316
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Study Endpoints
Primary Endpoints
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
Day 1 through day 57

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

Secondary Endpoints
Change from baseline in sweat chloride levels
Baseline to Day 15 in each treatment period
Concentration of SION-719 in plasma and change of concentration of SION-719 in plasma.
Day 1 through day 57
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Crossover Treatment Sequence 1: SION-719 followed by placebo-to-match SION-719EXPERIMENTALParticipants 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-719EXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
SION-719DRUGAll participants receive SION-719, as specified by their treatment sequence assignment
Placebo-to-match SION-719DRUGAll participants receive placebo to match SION-719, as specified by their treatment sequence assignment
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites13

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 modific...

Countries:United StatesAustralia
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Competitive Landscape -Cystic Fibrosis 18 trials (matched to "Cystic Fibrosis (CF)")
CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX9PHASE3VX-121/TEZ/D-IVA
Sionna Therapeutics, Inc.SION2PHASE2SION-719
BiomX Inc.PHGE1PHASE2BX004
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Krystal Biotech, Inc.KRYS1PHASE1KB407
Illumina, Inc.ILMN1 - Undisclosed
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07108153Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07108153studyFirstPostDate: changed