Purpose of this Study
In this study, everyone will receive a medicine called ianalumab that is given through a vein. People will get this treatment once every four weeks for four doses. During this time, they will come to the clinic each week to have blood tests to check their platelet levels. They will also take another medicine chosen by the study doctor to help increase platelets.
After the last dose of the study medicine, participants will continue to have weekly blood checks for 16 weeks. After that, they will have blood checks once a month for one year. The goal is to closely watch how their blood counts change over time and see how well the treatment works.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old and have a blood condition called immune thrombocytopenia or a related condition called Evans syndrome. They must have had some improvement from past treatments, such as steroids or immune therapy, but the improvement did not last. Their platelet level must be low, which can increase the risk of bleeding.
For people with Evans syndrome, they must have low platelets along with another blood problem where red blood cells break down. People cannot join if they have been taking certain platelet boosting medicines for a long time, had their spleen removed recently, or received certain immune treatments in the past few weeks.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to see how well people can take a medicine called ianalumab when it is used together with another treatment that helps the body make more platelets. Platelets are important because they help stop bleeding. Researchers will watch closely for side effects and check if these medicines help increase platelet levels. The goal is to see if this combination of treatments is safe and helps people with this blood condition.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2 open label study to evaluate the tolerability of ianalumab (VAY736) with investigator’s choice thrombopoietin receptor agonist (IC TPO-RA) in patients with primary immune thrombocytopenia (ITP) previously treated with at least one treatment
Principal Investigator
Ara
Metjian
Protocol Number
PRO00120255
NCT ID
NCT07421167
Phase
II
Enrollment Status
Pending Open to Enrollment