Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta (NCT07108153)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: National Jewish Health — Denver, Colorado
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- National Jewish Health — Denver, Colorado
- University of Iowa — Iowa City, Iowa
- Johns Hopkins — Baltimore, Maryland
- Boston Children's Hospital — Boston, Massachusetts
- Washington University — St Louis, Missouri
- New York Medical College — Hawthorne, New York
- Columbia University — New York, New York
- University Hospital of Cleveland — Cleveland, Ohio
- Medical University of South Carolina — Charleston, South Carolina
- University of Washington — Seattle, Washington
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Gold Coast University Hospital — Southport, Queensland
- Monash University — Melbourne, Victoria
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cystic Fibrosis (CF)
- Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care — Santa Ana, California
- Rethinking Early Airway Clearence Therapies — Birmingham, Alabama
- MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . — Toronto, Ontario
- Nutrition Supplement for Cystic Fibrosis — Columbus, Ohio
- Study to Enable New Diagnostics for Pulmonary Microbes in People With CF — La Jolla, California
Explore by condition: All Cystic Fibrosis (CF) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.