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Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase 2a Randomized, Double-blind, Placebo-controlled Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Physician-prescribed Trikafta® in People With Cystic Fibrosis Who Are Homozygous for the F508del Mutation

NCT07108153•Sionna Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 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 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.

Locations (13)

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

Key Dates

Start Date

November 3, 2025

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Cystic Fibrosis (CF)

Interventions

SION-719

DRUG

Placebo-to-match SION-719

DRUG

Contacts

VP, Head of Medical Affairs & Patient Advocacy

CONTACT

617-819-1389 medinfo@sionnatx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population

The School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy

Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.

Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy

Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Reference Center