What is the ILLUMINATE clinical research study?
If you have been diagnosed with PAH, please know that you are not alone in your medical journey. PAH is a rare but serious and progressive disease. Each year, around 4 in every 1 million people are expected to be diagnosed with it.
Currently, we are working on developing potential treatments for PAH. ILLUMINATE is a clinical research study that aims to see how well an investigational treatment works and how well it is tolerated in adults with PAH who are also taking other PAH medicines.
Am I eligible?
What are the study treatments?
Investigational treatment: There are two ways of administering the investigational treatment. In the first 6 months, you will receive the investigational treatment once a month via a drip into a vein (IV infusion). After that, you may enter the Extended Treatment Period. In this period, the investigational treatment is administered under the skin once a week (subcutaneous (SC) injection). You will be trained to administer the study drug yourself.
Placebo: A placebo looks like the investigational treatment but does not contain any real medicine. Researchers can tell whether an investigational treatment is effective by understanding if it works better than a placebo.
There is a Treatment Period that lasts 6 months. During this period, you will be randomly assigned to 1 of 3 treatment groups. You will not be able to choose your treatment group. One group will receive the investigational treatment at a low dose, one group will receive it at a high dose and one group will receive the placebo. All study treatments will be given as an IV infusion once a month.
The Treatment Period is ‘double-blinded’, which means neither you nor your study doctor or study team will know which study treatment you are receiving. However, if necessary for a significant medical event or medical emergency, they can find out which group you are in.
Once you have completed the Treatment Period, and your study doctor and you believe that you should continue receiving the investigational treatment, you will continue to the Extended Treatment Period. In this period, if you were receiving the investigational treatment at a low dose in the Treatment Period, you will receive the investigational treatment at a low dose subcutaneously. If you were receiving the investigational treatment at a high dose in the Treatment Period, you will receive the investigational treatment at a high dose subcutaneously.
If you were receiving placebo in the Treatment Period, you will be randomly assigned to 1 of 2 treatment groups: low dose investigational treatment subcutaneously or high dose investigational treatment subcutaneously.
During this period, all participants will receive the investigational treatment once a week.
The Extended Treatment Period is ‘open label’, which means you and your study team will know which study treatment you are receiving.
You will also continue taking your PAH medication in addition to the study treatments.
What can I expect if I participate?
Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your role and responsibilities if you join the ILLUMINATE study. You may leave the study at any time without it affecting your regular healthcare.
If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, such as blood and urine tests, and answering questions about your health. Your participation may last at least 9 months and up to about 2 and a half years.
There will be no cost to you for the study treatments, visits, tests or supplies that are required for the study. Reasonable travel costs (such as fuel and bus/train tickets) and food costs will be refunded to you. The study team will discuss all of this with you.
How can I take part?
If you wish to take part in ILLUMINATE, you can fill in a short pre-screening questionnaire to see if you might be eligible.
Am I eligible?
What else do I need to know?
As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment might affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.
You may benefit from additional check-ups in addition to your regular care and have access to PAH specialists. There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may become better, stay the same or may even worsen. You are free to withdraw from the study for any reason and at any time.
This clinical research study will use an investigational drug product, the safety and efficacy of which have not been fully evaluated by Regulatory Authorities.
Find a study site near you
To find out more about ILLUMINATE, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.
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