About
myOpportunITy

Living with immune thrombocytopenia (ITP), also sometimes called idiopathic thrombocytopenic purpura, can sometimes feel like being on a rollercoaster. The ups and downs of managing platelet counts and symptoms associated with ITP while cycling through treatments can take its toll. Choosing to take part in a clinical research study could be a good opportunity to help find new treatment options for people living with ITP.

myOpportunITy is comprised of three clinical studies that are evaluating a potential new subcutaneous (under the skin) infusion called rozanolixizumab. This drug has already been studied in more than 100 people with different diseases including ITP, and the results have led to these larger studies which are now looking for volunteers.

The first two of these studies, called myOpportunITy 1 and myOpportunITy 2, will take place over up to 34 weeks to assess rozanolixizumab against a placebo (an infusion which contains no medicinally active ingredients). These two studies are identical and will run at the same time at different study sites (hospitals where the study is conducted), so each individual can only participate in one of them. In these studies, twice as many people will receive rozanolixizumab as placebo, so your chances of receiving this potential new treatment are two in three.

To participate in the 34-week myOpportunITy 1 or myOpportunITy 2 study, you must at the time of entering:*
  • Be 18 years of age or older
  • Be diagnosed with persistent or chronic primary immune thrombocytopenia (ITP) (i.e. have a diagnosis of primary ITP for at least three months)
  • Have a platelet count below 30 (<30x109/L)
  • Have received at least one previous treatment for ITP
*There are additional criteria that you will need to meet to participate in the study — the study team will assess and discuss these with you during a screening process. This discussion will also address whether you can remain on your current treatment.

If you complete the myOpportunITy 1 or myOpportunITy 2 study, you will have the option to enroll in the extended 60-week myOpportunITy 3 study, provided you meet the entry criteria. This study will evaluate rozanolixizumab for longer-term management of ITP without the use of placebo. This means that all participants in myOpportunITy 3 (including those previously treated with the placebo) will receive rozanolixizumab.

myOpportunity 1 study
2/3 will recieve rozanolixizumab
1/3 will receive placebo
myOpportunity 2 study
2/3 will recieve rozanolixizumab
1/3 will receive placebo
myOpportunity 3
extension study
everyone will recieve
rozanolixizumab

What should I know about myOpportunITy?

We worked together with people living with ITP to ensure our studies measure and evaluate what matters, and to give you the best possible care throughout the study.

In the myOpportunITy 1 or myOpportunITy 2 study, you will receive subcutaneous infusions of either rozanolixizumab or placebo every two weeks. Twice as many people will receive rozanolixizumab than placebo, so your chances of receiving this potential new treatment are two in three. In total you will have approximately 30 visits across up to 34 weeks, some of which can be home visits.

For participants who have had their spleen removed, the study could be up to 44 weeks in total due to additional vaccination assessments during the screening period.

Rescue therapy is allowed at any time it is needed and will be free of charge. As a general rule, you can continue on the study if you receive rescue therapy. Depending on which medications you are taking at the time of screening, you may be allowed to continue taking some of them. Talk to your study physician about this and they will let you know which medications are permitted.

Home visits are where a nurse visits you in your home and performs the tests and assessments there without you having to travel to the study site. If you prefer, you can go to the study site for these visits instead. Your study doctor will also help to decide if home visits are appropriate for you.

Subcutaneous delivery

An infusion of this potential new treatment is given under the skin, and not through an intravenous (IV) line. This process takes approximately 30 minutes and you’ll be observed for four hours after the first three infusions and for two hours after subsequent infusions.


Screening

If you volunteer to participate in the study, you will be screened by the study team at the study site. A study team typically consists of nurses and doctors, and can also include study coordinators or other staff involved in the study, but this can vary at each study site. During the study screening, members of the study team will be asking you questions and doing some tests to make sure the study is right for you. This discussion will also address whether you can remain on your current treatment.

For participants who have had their spleen removed, the screening period is longer than for those who still have a spleen. This extra time is to allow participants' vaccinations to be assessed and for certain vaccinations to be given, if needed.

The advantages of participation

myOpportunITy could help you learn more about your ITP while your health and wellbeing is closely monitored. Participants will be true partners in these clinical studies, in three important ways:

PERSONAL INSIGHTS
Taking part in these studies could be an opportunity for you to better understand your condition and might help you manage living with ITP
CLOSE MONITORING
Study doctors and their team will closely monitor your condition and wellbeing throughout the studies
OPEN COMMUNICATION
We encourage honest and open communication between participants and the study team

If you or someone you care about is living with immune thrombocytopenia (ITP), also sometimes called idiopathic thrombocytopenic purpura, you know how managing platelet counts and symptoms can take its toll on daily living. Feelings of uncertainty about the future are also common, especially for those cycling through treatments that don’t always work in the long term. myOpportunITy is evaluating a potential new treatment option for people with ITP, to try and improve the ups and downs of living with this sometimes unpredictable condition.

Why a clinical research study?

Clinical research studies can help advance the understanding of a disease. They are the most important way for researchers to find out if potential new treatments are effective and well tolerated. Studies like these are needed to be able to make new treatments available to patients.

myOpportunITy 1 and myOpportunITy 2 are Phase 3, randomized, double-blind, placebo-controlled studies; let’s break down those terms:

Phase 3: Clinical studies take place over four different phases to check that the potential new treatment works in the anticipated way and is well tolerated. A Phase 3 study is the last stage of research before a treatment can be authorized for use. If you wish to find out more about how clinical research works, you can look at the video in the Clinical Studies section on the ucb.com website (only available in English).

Randomized: In order to maintain the accuracy of the study, participants who receive the study drug or a placebo will be selected randomly—similar to drawing straws.

Double-blind: To ensure all data is collected in a fair way without judgment or preconceptions, neither participants nor the study team will know who is receiving the study drug and who is receiving a placebo.

Placebo-controlled: In order to test how effective the study drug is, researchers will compare it to a placebo. A placebo is similar to the study drug but contains no active ingredients. Some study participants will receive the study drug, while others will receive a placebo.

Why participate in a clinical study?

People decide to take part in clinical studies for a variety of reasons. Some want to contribute to medical research and to potentially help others with the same condition. Some may wish to try a different approach to treatment. Clinical studies are completely voluntary, and you can withdraw at any time.

See more information about clinical studies »

Our commitment

UCB, a global pharmaceutical company based in Belgium, is developing rozanolixizumab and is sponsoring the myOpportunITy studies.

We have listened and will keep listening to the evolving needs of participants throughout the myOpportunITy studies. UCB is engaging with organizations that support people with ITP to better understand their needs.

Find a
study site

myOpportunITy will be conducted at study sites around the world.

Have questions about myOpportunITy?

Find answers to frequently asked questions about the studies to help inform your decision to participate.