Trials / Recruiting
RecruitingNCT05668741
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
A Phase 1/2 Dose Escalation Study Evaluating the Safety, and Tolerability and Efficacy of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-522 mRNA therapy | Oral inhalation using nebulizer. |
| DRUG | IVA | Tablet for oral administration. |
Timeline
- Start date
- 2023-02-27
- Primary completion
- 2026-12-23
- Completion
- 2027-05-12
- First posted
- 2022-12-30
- Last updated
- 2026-03-25
Locations
43 sites across 10 countries: United States, Australia, Belgium, Canada, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05668741. Inclusion in this directory is not an endorsement.