All studies
Active not recruitingPHASE2INTERVENTIONAL

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma

This study aims to find the best dose of a new long-acting medicine, called GSK5784283, for adults aged 18 to 75 who have asthma that isn't well-controlled even with their usual treatments. The medicine works by blocking a protein called TSLP, which may be making asthma worse. The study has two parts. The first part will check how the medicine affects lung function, asthma control, and signs of inflammation in your breath and blood. The second part will look at the long-term safety and effects of taking the medicine. This research could lead to new ways to manage difficult-to-treat asthma.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
307
Start
10 Feb 2025
Estimated completion
09 Sep 2027

What is this study about?

This research study is about a new medicine called GSK5784283, designed for adults aged 18 to 75 who have asthma that continues to be a problem, even when they're using their regular asthma medications. The main goal is to figure out the best dose of this new medicine. We want to see how well it works and how safe it is.

Asthma can be tricky, and sometimes, even with standard treatments, it doesn't get fully under control. This new medicine works by targeting a specific protein in the body called TSLP, which scientists believe plays a role in causing asthma symptoms. By blocking this protein, the hope is to reduce asthma attacks and improve breathing.

The study is split into two phases. The first part will carefully check things like your lung function (how well you can breathe), how much your asthma is affecting you, and look for signs of inflammation in your body. The second part will then focus on how safe the medicine is over a longer period and what its lasting effects are. Finding new and better ways to control asthma, especially for those who struggle, is very important.

Key takeaways

  • New study for adults (18-75) with hard-to-control asthma.
  • Aims to find the right dose of a new medicine, GSK5784283.
  • Medicine blocks a protein (TSLP) that contributes to asthma.
  • Involves regular health checks, lung function tests, and blood/breath samples.
  • Participation includes close medical monitoring.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be between 18 and 75 years old and have been diagnosed with asthma for at least two years. Your asthma should still be active, meaning you've had an asthma flare-up in the past year, and it needs regular treatment with medium or high-dose inhaled steroids.

You also need to be using at least one other regular asthma medication, like a long-acting reliever or other preventative treatments, for at least three months. Your weight needs to be at least 40 kilograms (around 6 stone 4 pounds).

If you're a woman, you can join if you're not pregnant or breastfeeding. You must either be past childbearing age, or if you could still have children, you must be using a very reliable method of contraception throughout the study and for a short time afterwards.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 75 years old?
  2. Have you been diagnosed with asthma for at least 2 years?
  3. Have you had an asthma flare-up in the last year?
  4. Do you use regular medium or high-dose inhaled steroids for your asthma?
  5. Do you use at least one other regular asthma medication?
  6. Are you a woman who is not pregnant, not breastfeeding, and using reliable contraception if needed?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the study medicine (GSK5784283) or a placebo (a dummy medicine with no active ingredients). This study involves several visits to the clinic for assessments. These will include checks on your lung function, answering questions about your asthma control, and providing blood and breath samples to look for signs of inflammation. We’ll also be monitoring you closely for any side effects.

The study is divided into two parts. The first part focuses on finding the right dose and will likely involve more frequent check-ups. The second part will look at the longer-term effects and safety of the medicine. The total length of your participation will depend on which part of the study you are in, but it will involve regular follow-up appointments. More detailed information about the schedule will be provided if you’re interested.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving close medical attention for your asthma and access to a new treatment before it's widely available. However, there are also potential risks, as with any new medicine. You might experience side effects from the study medication, or the medicine might not help your asthma. You will be closely monitored for any health changes. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (133)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Little Rock, United States
  • GSK Investigational Site
    Verified postcode
    Long Beach, United States
  • GSK Investigational Site
    Verified postcode
    Los Angeles, United States
  • GSK Investigational Site
    Verified postcode
    Redding, United States
  • GSK Investigational Site
    Verified postcode
    Riverside, United States
  • GSK Investigational Site
    Verified postcode
    Sacramento, United States
  • GSK Investigational Site
    Verified postcode
    San Jose, United States
  • GSK Investigational Site
    Verified postcode
    Colorado Springs, United States
  • GSK Investigational Site
    Verified postcode
    Lakewood, United States
  • GSK Investigational Site
    Verified postcode
    Wheat Ridge, United States
  • GSK Investigational Site
    Verified postcode
    New Haven, United States
  • GSK Investigational Site
    Verified postcode
    Aventura, United States

Common questions

What is uncontrolled asthma?

Uncontrolled asthma means your asthma symptoms are still bothering you, or you're still having flare-ups, even when you're using your regular asthma medicines.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers understand if the new medicine is truly effective.

What is TSLP?

TSLP is a natural protein in your body that can sometimes cause inflammation, which makes asthma symptoms worse. This new medicine aims to block its action.

Why are there two parts to the study?

The first part helps find the best dose of the medicine. The second part then checks how safe and effective that dose is over a longer period.

Will I know if I'm getting the real medicine or the placebo?

No, this is usually 'blinded' so neither you nor the study team will know who is getting what. This helps ensure the results are fair and unbiased.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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