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RecruitingPHASE2INTERVENTIONAL

A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.

This study is testing a new medication called AZD8965 for people suffering from Idiopathic Pulmonary Fibrosis (IPF). We want to find out how well different doses of AZD8965 work, how safe they are, and if they cause any side effects compared to a 'dummy' drug (placebo). The study will include people with IPF who are currently taking other approved IPF medicines, those taking a combination of these medicines, or those not on any antifibrotic treatment at all. We hope to better understand if AZD8965 could be a helpful new option for managing IPF. Around 360 people from around the world will take part in this 24-week study.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
359
Start
11 Jun 2026
Estimated completion
14 Sep 2028

What is this study about?

This study is about a new drug called AZD8965, which is being tested for a lung condition called Idiopathic Pulmonary Fibrosis (IPF). IPF causes scarring in your lungs, making it harder to breathe over time. Medical researchers are always looking for new ways to help people with IPF, and this study is an important step in that process.

The main goal of this particular study is to see if AZD8965 is helpful for people with IPF. We want to understand if it can slow down the disease, improve symptoms, and if it's safe to use. We'll be looking at different doses of AZD8965 to find out if there's an ideal amount that helps without too many side effects.

Participants in the study will either receive one of three doses of AZD8965 or a 'placebo', which looks like the drug but doesn't contain any active medicine. This allows us to fairly compare the new drug's effects. The study also includes people who are already taking other IPF medicines, so we can see how AZD8965 works alongside existing treatments, or if they are not currently taking any medicine for IPF.

Key takeaways

  • Tests a new drug (AZD8965) for Idiopathic Pulmonary Fibrosis (IPF).
  • Compares different doses of AZD8965 to a dummy drug (placebo).
  • Includes people with IPF, whether they are on other treatments or not.
  • The study lasts about 24 weeks (six months).
  • Aims to understand the drug's effectiveness, safety, and side effects.

Who may be eligible?

To join this study, participants need to be at least 40 years old and have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). You might be eligible whether you are currently taking approved medicines for IPF (like nintedanib or pirfenidone) or not taking any such medicine.

There are also some health requirements related to your lung function. Your forced vital capacity (FVC), which measures how much air you can breathe out after a deep breath, needs to be at least 45% of what's expected for someone your age and size. Your DLCO (diffusion capacity of the lung for carbon monoxide), which measures how well oxygen gets into your blood from your lungs, also needs to be at least 25% of what's expected.

However, you wouldn't be able to join if you have lung disease other than IPF, or if your lung scans show more emphysema than scarring. You also couldn't take part if you've recently had a sudden worsening of your IPF, a chest infection, certain heart problems (like a recent heart attack or heart failure), or if you've had an organ transplant or are likely to need a lung transplant.

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 40 years old or older?
  2. Do you have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
  3. Is your FVC lung function test at least 45% of normal?
  4. Is your DLCO lung function test at least 25% of normal?
  5. Do you NOT have other lung diseases besides IPF?
  6. Have you NOT had a recent worsening of your IPF or a chest infection?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in this study for about 24 weeks, which is roughly six months. During this time, you would receive either a specific dose of AZD8965 or a placebo (a dummy drug). Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind' and helps ensure the results are fair.

You would have several visits to the clinic for various checks and tests. These might include blood tests, lung function tests (like the ones you already have for IPF), and assessments of how you are feeling. The study team will explain exactly what each visit involves, how much time it will take, and when you need to come in. You would be given the study medication to take as instructed by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as contributing to medical knowledge that could help future patients with IPF, and potentially receiving a new treatment that might improve your condition. However, there are also potential risks; the new drug may cause side effects that are not yet fully known, or it might not work as expected. You will be closely monitored by the study team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (190)

  • Research Site
    Verified postcode
    Birmingham, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Phoenix, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Phoenix, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Loma Linda, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Newport Beach, United States· Recruiting
  • Research Site
    Verified postcode
    Sacramento, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Stanford, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Aurora, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Denver, United States· Not yet recruiting
  • Research Site
    Verified postcode
    Ocala, United States· Withdrawn
  • Research Site
    Verified postcode
    Weston, United States· Not yet recruiting

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a disease where your lungs become scarred and stiff, making it harder to breathe. 'Idiopathic' means the cause is unknown.

What does 'Phase IIb' mean?

This refers to a stage of drug testing. In Phase IIb, researchers are looking closely at how well the drug works and what dose is best, after initial safety checks have been done.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting the drug or a placebo?

No, neither you nor your study doctor will know. This is called 'double-blind' and ensures the study results are as unbiased as possible.

How long will I be in the study?

Each participant will be in the study for approximately 24 weeks, or about six months.

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 "A Phase IIb Study to Evaluate AZD8965 in Participants With I…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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