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Vx-522

Clinical trials are investigating Vx-522 in people with cystic fibrosis. This article explains what the study looked at, including safety, tolerability, and immune response, and who could take part. The trial also included a group receiving Vx-522 with ivacaftor.

Table of Contents

Trial overview

The available clinical trial studied Vx-522 in people with cystic fibrosis.[1] It was an interventional study, which means researchers gave a study treatment and then measured the effects.[1] The trial was Phase 1/2 and is listed as Completed.[1]

Study design and treatment groups

The study included a single ascending dose part, often called SAD, to evaluate safety and tolerability after one dose.[1] It also included a multiple ascending dose part, called MAD, to evaluate safety and tolerability after repeated doses.[1] One treatment arm studied Vx-522 together with ivacaftor, which is named in the trial data as a co-administered treatment.[1]

The intervention list shows Vx-522 as a nebuliser dispersion given by inhalation, and ivacaftor as an oral tablet in one arm.[1] Nebuliser dispersion means the medicine is turned into a mist for breathing in.[1]

Who participated

The trial enrolled 36 subjects with cystic fibrosis.[1] The source data do not provide more detailed inclusion or exclusion rules, so the main known target population is people with cystic fibrosis.[1]

What was measured in the study

The main outcome was safety and tolerability through the Week 8 visit.[1] Safety was checked using adverse events, clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry, spirometry, and immune response to Vx-522 components and CFTR protein.[1]

Adverse events are unwanted medical problems that happen during a study, whether or not they are caused by the treatment.[1] Pulse oximetry is a simple test that measures oxygen level in the blood, and spirometry is a breathing test that checks lung function.[1]

What this article focuses on

This article focuses on the clinical research questions behind Vx-522, not on how the treatment works in the body.[1] The key questions in the trial were whether Vx-522 could be given safely, how well it was tolerated, and how the body responded over time in people with cystic fibrosis.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2023-504786-23-00Phase 1/2Cystic FibrosisCompleted36

FAQ

  • What is being studied in the Vx-522 trial? The trial studied Vx-522 in people with cystic fibrosis. It looked mainly at safety, tolerability, and immune response, which means how the body reacted to the treatment.
  • Who could take part in this trial? The study enrolled subjects with cystic fibrosis. The trial data do not give more detailed entry rules in the source provided.
  • What phase was the Vx-522 study? This was a Phase 1/2 study. Early phase trials like this are usually designed to check safety first and also look for early signs that the treatment may be useful.
  • What treatment groups were included? The study included single ascending doses of Vx-522, multiple ascending doses of Vx-522, and a group that received Vx-522 together with ivacaftor. Ivacaftor was given as part of one treatment arm.
  • What condition was this trial focused on? The trial focused on cystic fibrosis. That is the only condition listed in the source data.

Ongoing Clinical Trials on Vx-522

  • Study on VX-522 and Ivacaftor for Adults with Cystic Fibrosis Unresponsive to CFTR Modulator Therapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Italy The Netherlands Spain Sweden

Glossary

  • Cystic fibrosis: A long-term inherited disease that affects the lungs and other organs. In this trial, it was the condition being studied.
  • Phase 1/2: An early stage of clinical research. Phase 1 usually focuses on safety, and Phase 2 adds more testing to learn whether the treatment may help.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Single ascending dose (SAD): A study part where one dose is given and then higher doses are tested in later groups.
  • Multiple ascending dose (MAD): A study part where several doses are given over time, often with dose levels increased in later groups.
  • Safety: How well a treatment can be given without causing serious problems.
  • Tolerability: How well people can handle a treatment, including how manageable side effects or discomfort are.
  • Adverse events: Unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • Clinical laboratory values: Results from blood and urine tests that help researchers check body function during the study.
  • ECG: A test that records the heart’s electrical activity. It is also called an electrocardiogram.
  • Spirometry: A breathing test that measures how well the lungs move air.
  • Immune response: How the body’s defense system reacts to the study treatment or parts of it.

References