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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVG-2089 | Experimental | NVG-2089 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVG-2089 | Drug | Study Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate incidence, nature and severity of Treatment Emergent Adverse Events (TEAEs) | From enrollment to end of treatment Week 20 | |
| Evaluate incidence, nature and severity of Serious Adverse Events (SAEs) | From enrollment to end of treatment Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants achieving a response. |
| From enrollment to Treatment Completion up to Week 20 |
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Inclusion Criteria:
Exclusion Criteria:
Secondary forms of ITP (e.g., ITP secondary to infection, autoimmune diseases, lymphoproliferative diseases and medications).
History of splenectomy.
History of malignancy, unless the participant received treatment with curative intent. Participants with fully excised non-melanoma skin cancer or cervical cancer are allowed.
History of solid organ transplant.
Planned or anticipated medical or surgical procedure, including dental procedure, during the timeframe of the study conduct.
Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening, including active viral infection at screening.
Any medical condition that, in the opinion of the investigator, would interfere with study evaluations or procedures, and/or put the participant at increased risk.
ECG findings of QTcF > 450 msec (males) or > 470 msec (females), poorly controlled atrial fibrillation or other clinically significant abnormalities.
Other significant organ dysfunction, including but not limited to, hematologic, renal, or hepatic dysfunction, as evidenced by:
Any of the following at screening:
Transfusion of blood, blood products (including immune globulin), or plasmapheresis within 4 weeks prior to screening.
Change in current ITP therapy (e.g., prednisone, methylprednisone, mycophenolate, dapsone, danazol, azathioprine, or TPO receptor agonist) or dose within 4 weeks prior to screening.
Receipt of dexamethasone within 4 weeks prior to screening.
Receipt of rituximab or an anti-CD20 agent within 6 months prior to screening.
Receipt of an neonatal Fc receptor (FcRn) inhibitor within 12 weeks prior to screening.
Receipt of IVIg within 4 weeks prior to screening.
Receipt of another investigational drug within 4-weeks or 5 half-lives (whichever is longer) prior to screening.
Concurrent treatment with other monoclonal antibody and/or Fc therapies.
Current or past history (within 12 months of screening) of alcohol, drug, or medication abuse. Positive urine drug screen at screening visit.
Pregnant or lactating women and those intending to become pregnant during the study or are unwilling to apply an effective birth control method (such as implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence, or vasectomized partner) up to 90 days after last study drug administration.
Poor venous access.
A known allergy to study drug and/or any of its components.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuvig Clinical Trials | Contact | 650 292-2184 | clinicaltrials@nuvigtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Recruiting | Greenville | North Carolina | 27834 | United States |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |