Actively Recruiting
Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia
Led by Nuvig Therapeutics, Inc. · Updated on 2025-07-31
10
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and female participants, age 18 to 80 years at time of screening.
- Diagnosis of persistent (>3 months and 3 months) or chronic (>12 months) primary ITP.
- History of response to at least one previous ITP therapy (platelet count increase to 50,000 cells/mm3 with 20,000 cells/mm3 increase).
- Asymptomatic or minor mucocutaneous bleeding with platelet count between 20,000 and 50,000 cells/mm3 on two occasions.
- (US only) If screening platelet count >30,000 and <50,000 cells/mm3, participant must be on at least one other ITP treatment with insufficient response.
- Prior IVIg therapy responders with no loss of response while on treatment.
- Female participants of childbearing potential must have negative pregnancy tests at screening and Day 1.
- Female participants sexually active with male partners of reproductive potential must use double contraception from 28 days before screening through 90 days after last dose; abstinence acceptable if usual lifestyle.
- Male participants with female partners of reproductive potential must use highly effective barrier contraception during study and for 90 days after last dose.
- Participant or legally authorized representative capable of providing signed informed consent and following study requirements.
You will not qualify if you...
- Secondary forms of ITP (infection, autoimmune diseases, lymphoproliferative diseases, medications).
- History of splenectomy.
- History of malignancy unless treated with curative intent; non-melanoma skin or cervical cancer allowed.
- History of solid organ transplant.
- Planned or anticipated medical or surgical procedures during study period.
- Active or chronic uncontrolled bacterial, viral, or fungal infection at screening.
- Any medical condition that interferes with study or increases risk per investigator judgment.
- ECG abnormalities: QTcF >450 msec (males), >470 msec (females), poorly controlled atrial fibrillation, or other significant abnormalities.
- Significant organ dysfunction (hematologic, renal, hepatic) by specified laboratory criteria.
- Active HBV, HCV, or HIV infection.
- Recent transfusions, changes in ITP therapy, or certain drug treatments within defined timeframes before screening.
- Treatment with rituximab or anti-CD20 agents within 6 months prior to screening.
- Treatment with neonatal Fc receptor inhibitors within 12 weeks prior to screening.
- Treatment with IVIg within 4 weeks prior to screening.
- Use of other investigational drugs within 4 weeks or 5 half-lives prior to screening.
- Concurrent treatment with other monoclonal antibody or Fc therapies.
- Alcohol, drug, or medication abuse within 12 months or positive drug screen.
- Pregnant or lactating women or unwilling to use effective birth control through 90 days after last dose.
- Poor venous access.
- Known allergy to study drug or its components.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nuvig Site
Westbury, New York, United States, 11590
Actively Recruiting
Research Team
N
Nuvig Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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