Are you a healthcare professional?

Please confirm that you are a healthcare professional to access information to help you identify and support any of your patients who may participate in the myOpportunITy studies.

Let’s try to improve the
ups and downs of ITP

People with immune thrombocytopenia (ITP) and their healthcare professionals develop strong relationships, built on trust. We need your help to enroll eligible patients for three Phase 3 studies evaluating the efficacy and safety of subcutaneous rozanolixizumab.

We are at a moment in time when there is much to be done for those affected by ITP. People living with this rare condition often face a life of ups and downs, managing platelet counts and symptoms associated with ITP while cycling through treatments. There is a need to reduce the burden on people living with ITP and offer more options with a potential for longer-term management in this often unpredictable disease.

As we at UCB strive to advance the understanding of the condition and to work towards improving health outcomes, we are excited by the possibility of rozanolixizumab providing a new therapeutic option for people living with ITP.

Rozanolixizumab

Rozanolixizumab is a subcutaneously infused, fully humanized, monoclonal antibody, that specifically targets the neonatal Fc receptor (FcRn). Targeted inhibition of FcRn leads to accelerated destruction of IgG (including pathogenic IgG) by the natural lysosomal degradation pathway. This reduction of the pathogenic IgG concentration makes rozanolixizumab a potential new treatment option for patients with primary immune thrombocytopenia (ITP).

myOpportunITy

myOpportunITy is comprised of three Phase 3 clinical studies (TP0003, TP0004 and TP0006) that are evaluating the efficacy and safety of rozanolixizumab.

The first of these (TP0003, also called myOpportunITy 1 and TP0006, also called myOpportunITy 2) are both Phase 3 multicenter, double-blind, randomized, placebo-controlled studies that will take place over up to 34 weeks (or up to 44 weeks for splenectomized participants, to allow for a prolonged screening period).

These studies will provide the required data to evaluate the efficacy, safety and tolerability of rozanolixizumab in adults with persistent or chronic primary ITP who are at risk of bleeding and need to increase their platelet counts.

TP0004, also called myOpportunITy 3, is a 60-week open-label extension study to assess the long-term efficacy and safety of rozanolixizumab.

Details about the studies

Both the 34-week studies (TP0003 & TP0006) consist of a screening period, a study treatment period, and a safety follow-up period.

Screening Period
Study Treatment Period
2/3 will recieve rozanolixizumab
1/3 will receive placebo
Safety follow-up period

After 2:1 randomization, either rozanolixizumab or placebo will be administered every two weeks during the study treatment period. During the study, participants will have a total of approximately 30 visits, some of which can be home visits, if possible.

All participants who complete one of the 34-week studies and meet the eligibility criteria will have the option to enroll in an open-label 60-week extension study (TP0004, also called myOpportunITy 3). This will evaluate the effectiveness and safety of rozanolixizumab for longer-term management of ITP.

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

On all the myOpportunITy studies, rescue therapy is allowed at any time if this is necessary. Participants can still continue on the study if they receive rescue therapy. Some concomitant medications are also permitted during the study at stable doses.

We encourage honest and open communication between participants and the study team to ensure every person who chooses to take part is listened to and treated with care. Participants are also encouraged to continue seeing their current doctor to update them on their health and study experience.

Which of your patients is eligible?

Enrollment is open to those who are:*

  • Be 18 years of age or older
  • Be diagnosed with persistent or chronic primary immune thrombocytopenia (ITP)
  • Have a platelet count below 30 (<30x109/L)
  • Have received previous treatment for ITP (documented intolerance or insufficient response to appropriate courses of standard of care ITP medication AND prior history of a response to a previous ITP therapy)
*There are additional inclusion criteria. To be eligible to participate in this study, your patients must meet all the inclusion and exclusion criteria at screening, reconfirmed at the baseline visit.

Helping to enroll participants

For the TP0003 and TP0006 studies, we need to enroll about 30 participants per study for a formal interim analysis and then a further 30 to 75 participants may be recruited into the study across about 50 to 60 sites per study in North America, Asia, and Europe.

Only with your support, can we help advance medical research for this rare condition and provide a potential new treatment option for patients.

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.