An Open-Label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants With Immune Thrombocytopenia
Nuvig Therapeutics, Inc.
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 ≤50,000 cells/mm3, measured on 2 occasions at least 5 days apar…
Interventions
- DrugNVG-2089
Study Treatment
Location
- East Carolina UniversityGreenville, North Carolina