All studies
RecruitingPHASE2INTERVENTIONAL

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

This study is for adults aged 18-75 with asthma that isn't fully controlled, even with regular inhaled steroid medicines. Participants will try a new medication called tozorakimab, given by injection, or a dummy treatment (placebo). The main goals are to find the right dose of tozorakimab and see how safe and effective it is. By taking part, you could help researchers learn more about new ways to manage asthma and potentially improve treatments for others in the future. The study is double-blind, meaning neither you nor your doctor will know if you're receiving the new medicine or the placebo.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
540
Start
26 Mar 2025
Estimated completion
16 Mar 2028

What is this study about?

This study is looking into a new treatment called tozorakimab for adults who have asthma that isn't fully under control. This means that even with their usual medium-to-strong inhaled steroid medicines, their asthma symptoms are still causing problems.

The research is split into groups, with some participants receiving different doses of tozorakimab and others receiving a 'placebo' – which is a dummy treatment that looks just like the real medicine but contains no active drug. This is done so researchers can fairly compare the effects of the new medicine against not having it. The study is 'double-blind', meaning neither you nor your study doctor will know whether you're getting tozorakimab or the placebo. This helps make sure the results are as unbiased as possible.

The main aim is to understand if tozorakimab can help improve asthma control, reduce asthma attacks (exacerbations), and if it's safe to use. Finding new and better ways to manage asthma is very important for many people, and this study aims to contribute to that knowledge.

Key takeaways

  • Tests a new medicine (tozorakimab) for adults with uncontrolled asthma.
  • Compares different doses to a dummy treatment (placebo).
  • Aims to find out if the new medicine is safe and effective.
  • Involves regular clinic visits, injections, and health monitoring.
  • Participation could help improve future asthma treatments.

Who may be eligible?

To be considered for this study, you need to be an adult aged between 18 and 75, with a clear diagnosis of asthma for at least a year. Your asthma should not be fully controlled, even though you're using medium or high doses of inhaled steroids along with another type of asthma medicine called a LABA. You would also need to have had a certain number of asthma attacks in the last year, and meet specific blood or breath test results related to your asthma.

There are also some reasons why you might *not* be able to join. For example, if you've recently had a chest infection treated with antibiotics, or if you have other serious lung conditions besides asthma. The study can't include current smokers, or former smokers with a history of heavy smoking, or people with certain heart conditions, active infections like tuberculosis, or a current cancer diagnosis.

Women who could become pregnant would need to have a negative pregnancy test and agree to use effective contraception during the study. Men would also need to use contraception as advised.

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 a year?
  3. Is your asthma still bothering you, even with your current inhalers (medium/high dose steroid + LABA)?
  4. Have you had at least one asthma attack in the past year?
  5. Do you *not* currently smoke or have a history of heavy smoking?
  6. Are you generally in good health apart from your asthma, without certain other serious conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine, tozorakimab, or a placebo (dummy treatment) by an injection under your skin. You'll have regular visits to the clinic for health checks, to discuss your asthma symptoms, and to have various tests, such as lung function tests and blood tests. You'll also likely be asked to keep a daily diary of your asthma symptoms. The study team will explain everything in detail, including how long you'll be involved and what each visit will entail. All study-related medicines and tests will be provided at no cost.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new, experimental treatment for your asthma that might improve your symptoms or reduce asthma attacks. You will also receive close medical attention and monitoring throughout the study. However, there are potential risks too; the new medicine might cause side effects, or it might not work for you. You might also experience discomfort from blood tests or injections. It's important to remember you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (213)

  • Research Site
    Verified postcode
    Bakersfield, United States· Recruiting
  • Research Site
    Verified postcode
    Huntington Beach, United States· Withdrawn
  • Research Site
    Verified postcode
    La Mesa, United States· Terminated
  • Research Site
    Verified postcode
    Newport Beach, United States· Recruiting
  • Research Site
    Verified postcode
    San Jose, United States· Recruiting
  • Research Site
    Verified postcode
    Wilmington, United States· Terminated
  • Research Site
    Verified postcode
    Cutler Bay, United States· Suspended
  • Research Site
    Verified postcode
    Hialeah, United States· Suspended
  • Research Site
    Verified postcode
    Hialeah, United States· Suspended
  • Research Site
    Verified postcode
    Leesburg, United States· Withdrawn
  • Research Site
    Verified postcode
    Miami, United States· Suspended
  • Research Site
    Verified postcode
    Miami, United States· Suspended

Common questions

What is 'uncontrolled asthma'?

This means your asthma symptoms are still causing problems, even though you're using your regular medicines. You might have frequent symptoms, need your reliever inhaler often, or wake up at night due to asthma.

What is a 'placebo'?

A placebo is a dummy treatment. It looks exactly like the real study medicine but contains no active drug. It helps researchers compare the effects of the new medicine fairly.

How will I receive the study medicine?

The study medicine will be given as an injection just under your skin.

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

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete.

What kind of tests will I have?

You'll have regular health checks, lung function tests (like breathing into a machine), and blood tests to monitor your health and how your asthma is responding.

How to find out more

AstraZeneca Clinical Study Information Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "Dose Range Finding Study to Assess Efficacy and Safety of To…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.