Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
NCT ID: NCT07108153
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
16 participants
INTERVENTIONAL
2025-11-03
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Crossover Treatment Sequence 1: SION-719 followed by placebo-to-match SION-719
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.
SION-719
All participants receive SION-719, as specified by their treatment sequence assignment
Placebo-to-match SION-719
All participants receive placebo to match SION-719, as specified by their treatment sequence assignment
Crossover Treatment Sequence 2: Placebo-to-match SION-719 followed by SION-719
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.
SION-719
All participants receive SION-719, as specified by their treatment sequence assignment
Placebo-to-match SION-719
All participants receive placebo to match SION-719, as specified by their treatment sequence assignment
Interventions
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SION-719
All participants receive SION-719, as specified by their treatment sequence assignment
Placebo-to-match SION-719
All participants receive placebo to match SION-719, as specified by their treatment sequence assignment
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Sionna Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sionna Therapeutics Inc.
Locations
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National Jewish Health
Denver, Colorado, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
New York Medical College
Hawthorne, New York, United States
Columbia University
New York, New York, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Washington
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Monash University
Melbourne, Victoria, Australia
Countries
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Central Contacts
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VP, Head of Medical Affairs & Patient Advocacy
Role: CONTACT
Phone: 617-819-1389
Email: [email protected]
Other Identifiers
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SION-719-201
Identifier Type: -
Identifier Source: org_study_id