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Study of NVG-2089 given by intravenous infusion in patients with immune thrombocytopenia to evaluate safety and effectiveness

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Immune Thrombocytopenia (ITP), a condition where the immune system mistakenly attacks and destroys blood platelets, leading to low platelet counts. The study will test a new medication called NVG-2089, which is given through intravenous infusion, alongside human normal immunoglobulin, a standard treatment for this condition.

The main purpose of this research is to evaluate how safe and well-tolerated NVG-2089 is when given to patients with ITP. The study will use gradually increasing doses of the medication to understand how patients respond to different amounts. Each participant will receive the treatment through an infusion into their veins.

During the study, researchers will monitor participants' platelet counts and any side effects that may occur. The treatment period may last several months, during which participants will have regular check-ups to assess their response to the medication. The study will track how well the treatment works by measuring changes in platelet counts and how long the treatment effects last.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your platelet count will be measured on two occasions to confirm it is between 20,000 and 50,000 cells/mm3

    If you are a female of childbearing age, you will need to take a pregnancy test

  2. Step 2

    Treatment preparation

    You will receive NVG-2089, a new medication given through an intravenous infusion (through a vein)

    The treatment will be administered in increasing doses to evaluate safety and effectiveness

  3. Step 3

    Treatment monitoring

    Your platelet count will be regularly monitored throughout the study

    Medical staff will track any side effects or reactions to the medication

    Blood samples will be taken to measure how the medication moves through your body

  4. Step 4

    Response assessment

    If your initial platelet count is below 30,000, success is defined as either doubling of platelet count or reaching 50,000 or higher

    If your initial platelet count is 30,000 or higher, success is defined as an increase of 20,000 or reaching 80,000 or higher

  5. Step 5

    Safety monitoring

    Throughout the study period, you will be monitored for any side effects or serious reactions to the medication

    The study will continue until December 2026

Who can join the trial?

8 criteria

  • Age between 18 and 80 years old at screening
  • Diagnosed with primary ITP (a condition affecting blood platelets) that has lasted either: - More than 3 months but less than 12 months, or - More than 12 months
  • Must have responded to at least one previous ITP treatment, showing an increase in platelet count to at least 50,000 cells/mm3 with a minimum increase of 20,000 cells/mm3
  • Current platelet count must be between 20,000 and 50,000 cells/mm3, measured twice, with either no symptoms or minor bleeding
  • If previously treated with IVIg (intravenous immunoglobulin), must have shown positive response (doubling of platelet count within 7 days of treatment)
  • Women who can become pregnant must: - Have negative pregnancy tests - Use two forms of birth control, including a barrier method - Continue birth control for 90 days after last study dose - Not donate eggs during the study period
  • Men with partners who can become pregnant must: - Use effective barrier birth control during the study - Continue birth control for 90 days after last study dose
  • Must be able to provide informed consent or have a legal representative who can provide consent

Who cannot join the trial?

13 criteria

  • Pregnancy, breastfeeding, or planning to become pregnant during the study
  • History of severe allergic reactions to medications or vaccines
  • Active bleeding or blood clotting disorders (besides ITP)
  • Major surgery within 3 months before starting the study
  • Participation in other clinical trials within 30 days before this study
  • Serious heart, liver, or kidney problems
  • Active infections or ongoing treatment with antibiotics
  • Use of blood thinners or anticoagulant medications
  • History of blood cancer or other types of cancer in the past 5 years
  • Uncontrolled high blood pressure
  • Substance abuse or alcohol dependency within the past year
  • Mental health conditions that could affect participation in the study
  • Any condition that, in the opinion of study doctors, would make participation unsafe
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Investigated drugs

NVG-2089 is an investigational medication given by intravenous (IV) injection that is being studied for the treatment of immune thrombocytopenia (ITP), a condition where the immune system attacks and destroys platelets in the blood. The medication is being tested at different dose levels to understand how safe it is and how well it works in patients with this condition.

What is already known about the treatment

NVG-2089 - An investigational medication administered intravenously for the treatment of Immune Thrombocytopenia (ITP), a condition where the immune system attacks blood platelets. This novel therapeutic agent is currently undergoing clinical trials to evaluate its safety, tolerability, and effectiveness in patients with ITP, with the study design featuring sequential single ascending doses to determine optimal dosing levels. While the exact molecular mechanism of action is still under investigation through clinical trials, the drug is being developed specifically to address the autoimmune component of ITP, potentially by modulating the immune response that leads to platelet destruction.

Investigated diseases

Immune Thrombocytopenia (ITP) - A rare autoimmune disorder where the immune system mistakenly attacks and destroys platelets in the blood. In this condition, the body produces antibodies that attach to platelets, leading to their premature destruction in the spleen. The reduced number of platelets in the blood affects the body's ability to form blood clots. This condition can develop suddenly or gradually over time and can affect people of any age. ITP can be either primary (developing on its own) or secondary (occurring alongside other medical conditions).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520359-26-00Protocol codeNVG-2089-200Estimated enrolment64 patientsSponsorNuvig Therapeutics Inc.

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