Clinical Trial Alert 01/19/2023

Cystic Fibrosis Foundation issued three clinical trial alerts on 01/19/2023: two enrolling, one results

Study to evaluate VX-522 in adults 18 years and older with cystic fibrosis.

Status: Enrolling

Description: This study will evaluate the safety and tolerability of VX-522, an investigational gene therapy, in adults with CF whose mutations are not responsive to CFTR modulator therapy. 

Age: 18 Years to 65 Years

Mutation: No Copies F508del

Fev1% Predicted: 40% or greater

Number of Visits: 8

Length of Participation: 6 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05668741

Study of ARV-1801 (ACG-701) for the treatment of pulmonary exacerbations in CF patients 12 years of age or older.

Status: Enrolling

Description: This study will evaluate the efficacy and safety of the study drug ARV-1801, an oral drug intended to treat infections in the lung. The study also will evaluate how the body process the drug. 

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 5

Length of Participation: 28 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05641298

SIMPLIFY: Study to evaluate stopping inhaled hypertonic saline or dornase alfa in people with CF who are taking Trikafta®

Status: Completed with results

Description: This study evaluated the effects and safety of stopping inhaled hypertonic saline or dornase alfa (Pulmozyme®) in teens and adults with CF who are also taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (Trikafta®). 

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 60% or greater

Number of Visits: 4

Length of Participation: 10 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04378153