ClinicaliQ Trial Snapshot
- A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) — Recruiting • Phase I • Cardiology / Cardiovascular • NCT05668741.
- 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.….
- Sponsor: Vertex Pharmaceuticals Incorporated.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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. Lead Sponsor: Vertex Pharmaceuticals Incorporated Start Date: 2023-02-27 Primary Completion: 2026-12-23
Eligibility Snapshot
- Key Inclusion Criteria: * Body mass index is less than () 50 kg * Stable CF disease * CFTR gene mutations on both alleles that are not responsive to CFTR modulator therapy o Example mutations include but are not limited to, mutations that do not produce CFTR protein (i.e., Class I): nonsense mutations (e.g., G542X, W1282X) and canonical splice mutations (e.g., 621+1G->T) * Forced expiratory volume in 1 second (FEV1) value for SAD: greater than or equal to (≥)40 percent (%), MAD: ≥ 50% to less than or equal to (≤) 90% Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.