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NCT07108153 · ClinicalTrials.gov registry record · Phase 2
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
A Phase 2 study of Cystic Fibrosis (CF), sponsored by Sionna Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 13
- Study locations
NCT07108153: Recruiting Phase 2 study of Cystic Fibrosis (CF), sponsored by Sionna Therapeutics.
NCT07108153 is a Phase 2 study of Cystic Fibrosis (CF) that is actively recruiting participants, run by Sionna Therapeutics. The registered enrollment target is 16 participants, below the 140-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (89% lower). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07108153, a Phase 2 study of Cystic Fibrosis (CF), is actively recruiting participants, sponsored by Sionna Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Adverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE), v. 5.0
Conditions Studied
Interventions
- DRUG SION-719
- DRUG Placebo-to-match SION-719
Study Locations (13)
New York
- New York Medical College - Hawthorne
- Columbia University - New York
Colorado
- National Jewish Health - Denver
Iowa
- University of Iowa - Iowa City
Maryland
- Johns Hopkins - Baltimore
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- Washington University - St Louis
Ohio
- University Hospital of Cleveland - Cleveland
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-11-03 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What NCT07108153 shows while recruiting
NCT07108153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 140-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Cystic Fibrosis (CF) appearing as the primary indexed condition, and to 2 interventions - of which SION-719 is the first listed.
NCT07108153 lists 13 locations in 12 states (New York, Colorado, Iowa).
Frequently Asked Questions
What is clinical trial NCT07108153 about?
NCT07108153 is a clinical study titled "Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta". 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.
What is the current status of trial NCT07108153?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2025-11-03. Estimated completion is 2026-07.
What conditions does trial NCT07108153 study?
This clinical trial studies the following conditions: Cystic Fibrosis (CF).
What interventions are being tested in trial NCT07108153?
The interventions under investigation include: SION-719 (DRUG), Placebo-to-match SION-719 (DRUG).
Who is sponsoring clinical trial NCT07108153?
This trial is sponsored by Sionna Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07108153 being conducted?
This trial has 13 study locations across Colorado, Iowa, Maryland, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis (CF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07108153's enrollment target sits among peer trials
16 14th of 14 higher than 1 of 14 other Cystic Fibrosis (CF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis (CF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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