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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis (CF)

In brief

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.

Key facts

Study ID

NCT07108153

Run by

Sionna Therapeutics Inc.

People needed

16

Starts

2025-11-03

Expected to finish

2026-07-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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