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 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 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.
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.
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.