Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia
Trial Parameters
Brief Summary
The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new drug that is being developed for treating patients with ITP. NVG-2089 is designed to mimic the effects of a protein called IVIg. NVG-2089 is designed to help the immune system by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports how the immune system works.
Eligibility Criteria
Inclusion Criteria: * Males and female participants, age 18 to 80 years at time of screening. * Diagnosis of persistent (\>3 months and ≤12 months), or chronic (\>12 months) primary ITP. If the participant has received prior treatment for ITP, they must have a history of response to at least one previous therapy (defined as increase in platelet count to ≥ 50,000 cells/mm3 with an increase of ≥ 20,000 cells/mm3 relative to platelet count prior to treatment). * Asymptomatic or with minor mucocutaneous bleeding AND platelet count of ≥ 20,000 to ≤50,000 cells/mm3, measured on 2 occasions. At least one measurement should be obtained during screening. Documented historical platelet count obtained within 4 weeks prior to screening will also be acceptable for one of the two readings. * (For US only) If at least one screening platelet count \>30,000 cells/ mm3 and \<50,000 cells/mm3, the participant must be on at least 1 other treatment for ITP with insufficient response as evidenced by platele