A trial to understand the effect of a new drug, HZN-825, in people with IPF

Upcoming study
Expected to open August 2021
This study is currently recruiting
Expected to close
This study is closed
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We will update this page with study results when available.
Information on study results are included below
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Ask your healthcare team about taking part in research

What next?

Original listing:

What next?

Original listing:

About this study

The clinical trial is designed to see if a new drug called HZN-825, can help people with IPF. The aim is to understand how the body responds to the new drug, and if it affects lung function.

People affected by IPF currently have limited treatment options to slow the progression of disease. New research studies such as this, are needed to gain valuable knowledge about better treatment options.

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What is involved?

You will be randomly assigned to one of 3 groups:

  1. Taking the new drug in the morning and a look alike medicine (placebo) in evening
  2. Taking the new drug in the morning and the evening
  3. Taking a look alike drug (placebo) in both the morning and evening

You would be asked to take part for up to 52 weeks, with the possibility of remaining in the study for another 52 weeks.

Tests will take place at different time points in the study. This may include lung function tests, six-minute walk test, questionnaires and other medical monitoring.

Patients, care providers and researchers will not know which group participants are in until the end of the initial 52-week study.

Summary of involvement

Taking a new drug or placebo tablets morning and evening

Lung function tests

Questionnaires

Other medical assessments

Can I take part?

You may be able to take part if you have a diagnosis of IPF and are aged 18 years and over.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.

To find our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

Aged 18 years or above

Diagnosis of IPF

No recent or planned change to your IPF treatment

There is a criteria for lung function, but this must be discussed with the research team

Estimated minimum life expectancy of more than 30 months for non-IPF related disease

You will not be able to join the study of any of the following applies:

Significant cardiovascular disease

Interstitial lung disease (ILD) that is not IPF

Active infection

Use of prednisone, cyclosporine or rifampin

Malignant condition in the past 5 years

Those not agreeing to use birth control (where applicable)

Pregnant or breastfeeding women

Current drug or alcohol abuse or history within the previous 2 years

Positive test for human immunodeficiency virus (HIV), active hepatitis

Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis

Previous organ transplant

Recent exposure to an experimental drug or experimental vaccine

What difference could taking part make?

Taking part in this clinical trial will help researchers to understand the potential effects of the new drug. The study will help to see if it has the potential to help people with IPF.

Taking part in research has the potential to make a difference for people who have IPF now and for future generations.

Where does the study take place?

Study locations

Liverpool

How to take part

Please discuss this with your healthcare team and Consultant in the first instance, to express your interest in the study and hearing about opportunities to take part in research.

Further information

The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.

If you have any questions about this research study, please speak to your medical team.

clinicaltrials@horizontherapeutics.com

This study is supported by

Horizon Therapeutics Ireland
Study ID number:
NCT05032066

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.

Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org