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The trial could be an excellent fit for you

Are you a former smoker diagnosed with COPD?

Are you a former smoker diagnosed with COPD?

The trial could be an excellent fit for you

What’s the clinical trial about?

This is a Phase 3 research study looking into the effectiveness and safety of a new investigational medication (itepekimab). We want to find out if it can help reduce the number of flare-ups (also known as exacerbations) that people with COPD have over the course of a year.

You may be able to take part if:

4 EASY STEPS

Take our eligibility survey

Find out if your eligible

Discuss the next steps with our study staff

Meet the medical team

What will I need to do to participate?

After determining your eligibility. You will:
  • Complete a screening visit to determine if the trial is right for you. During this period, you will receive an electronic device on which you will complete a short questionnaire on a daily basis.
  • During the treatment visits, you will be randomly assigned to receive
    • itepekimab once every 2 weeks
    • itepekimab once every 4 weeks or,
    • placebo once every 2 weeks
    • Some visits may include blood work, urine test, and breathing tests.
  • Once you have completed your treatment visits, you will have you will complete follow-up visits in which the study treatment will be stopped, and you will be asked to visit the clinic twice.

What is Itepekimab?

Itepekimab is a human monoclonal antibody (a type of protein) that blocks the activity of

interleukin-33 (IL-33) in your body (interleukins are proteins that stimulate the immune

response and can cause inflammation).

 

IL-33 may play a role in COPD, and blocking the effects of IL-33 may improve COPD symptoms.

Additional Information

To date, itepekimab has been studied in 7 studies (tests) in humans: 5 completed studies

and 2 ongoing studies. Of the 5 completed studies:

  • Study R3500-HV-1551: This study showed that itepekimab was safe to use in healthy volunteers.
  • Study R3500-AS-1619: This study showed that itepekimab was safe to use in adults with asthma.
  • Study ACT15102: The study showed that the use of itepekimab was safe, can reduce loss of asthma control (moderate or severe asthma attacks), and improve lung function.
  • Study R3500-AS-1633: Itepekimab was found to be safe in adults with mild allergic asthma.
  • Study ACT15104: Itepekimab prevented the worsening of COPD symptoms (exacerbations) in patients who were former smokers. Itepekimab was found to be safe.

What is a placebo?

A placebo is something that looks identical to the treatment that’s being investigated but doesn’t contain any active medication. The reason we give some participants a placebo is so we can compare the results of people who’ve taken tozorakimab with other people who’ve been through exactly the same process. It helps us ensure that any results we measure in this clinical trial are due to tozorakimab and not for any other reason.

How is the medication given?

You’ll be given the investigational medication (itepekimab) or placebo as an injection under the skin. The injection may be in your arm, abdomen, or thigh.

What other tests will I have?

As well as questionnaires to track your COPD symptoms, you’ll have a few other tests done throughout the trial. These include breathing tests, blood tests, a CT scan or chest x-ray, and an ECG to check your heart.

Will I be compensated?

 

This study will compensate each participant $100.00 for every completed study visit until the end of the study or withdrawal.

 

Being involved in our clinical trial won’t cost you anything. All trial-related costs above your usual care will be free. And don’t let travel costs put you off – we’re happy to talk about covering any expenses you need to take part in the study.