10 Participants Needed

NVG-2089 for Immune Thrombocytopenic Purpura

NC
Overseen ByNuvig Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Nuvig Therapeutics, Inc.
Must be taking: ITP treatments
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new drug, NVG-2089, aimed at treating Immune Thrombocytopenic Purpura (ITP), a condition where the immune system mistakenly attacks platelets, causing low platelet counts and bruising or bleeding. NVG-2089 mimics the effects of a protein called IVIg, helping the immune system reduce inflammation and function better. The study aims to assess the safety and effectiveness of NVG-2089 for people with ITP. Suitable participants are those who have had ITP for more than three months and continue to experience low platelet counts despite previous treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it does require that there be no changes in your ITP therapy or dose within 4 weeks before screening. You also cannot have received certain treatments like dexamethasone, rituximab, or IVIg within specific timeframes before screening.

Is there any evidence suggesting that NVG-2089 is likely to be safe for humans?

Research has shown that NVG-2089 is generally safe based on previous studies. This treatment mimics a protein called IVIg and aims to reduce inflammation by targeting specific body parts. In studies, patients with immune thrombocytopenic purpura (ITP) who received NVG-2089 demonstrated a good safety record, with serious side effects being rare. While these studies continue to focus on safety, some patients experienced mild side effects, such as headaches or mild nausea. Overall, current data suggest NVG-2089 is safe for people, but ongoing research will provide more information.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Immune Thrombocytopenic Purpura (ITP), which often include steroids or immunoglobulins, NVG-2089 is unique because it uses a novel mechanism of action. NVG-2089 targets specific pathways in the immune system to increase platelet production more directly and efficiently. Researchers are excited about NVG-2089 because it has the potential to provide a more targeted approach with fewer side effects, offering hope for patients who don't respond well to existing therapies.

What evidence suggests that NVG-2089 might be an effective treatment for ITP?

Research has shown that NVG-2089, the investigational treatment in this trial, is designed to mimic a protein called IVIg, which calms the immune system and reduces swelling. This is crucial for individuals with immune thrombocytopenic purpura (ITP), a condition where the immune system mistakenly attacks platelets. Early findings suggest that NVG-2089 may increase platelet counts by attaching to and activating certain body parts. This process supports the immune system and may better manage ITP symptoms. Although more research is needed, initial results appear promising for those considering this treatment.25678

Are You a Good Fit for This Trial?

Adults aged 18-80 with persistent or chronic primary Immune Thrombocytopenia (ITP) who've responded to previous treatments can join. They must have a certain platelet count and use effective contraception. Those with recent IVIg therapy should have had a positive response without losing it later.

Inclusion Criteria

I am between 18 and 80 years old.
I am a woman who can have children and have tested negative for pregnancy.
I can sign the consent form myself or have someone legally authorized to do it for me.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous NVG-2089 to evaluate safety, tolerability, and efficacy

8-9 weeks
Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NVG-2089
Trial Overview NVG-2089, a new drug for ITP that mimics the protein IVIg, is being tested for safety and effectiveness. It aims to reduce inflammation and improve immune function by binding to specific receptors in the body.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NVG-2089Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nuvig Therapeutics, Inc.

Lead Sponsor

Citations

Study of NVG-2089 given by intravenous infusion in ...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 ...
NVG-2089 for Immune Thrombocytopenic PurpuraThe 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 ...
Safety, Tolerability, and Efficacy of NVG-2089 in - ClinConnectNVG-2089 works by mimicking a natural protein that helps calm the immune system and reduce inflammation, potentially improving platelet counts and reducing ...
Clinical Trials Actively Recruiting in the USAThe 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 ...
Immune (Idiopathic) Thrombocytopenic Purpura (ITP) ...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 ...
Safety, Tolerability, and Efficacy of NVG-2089 in ...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- ...
Safety, Tolerability, and Efficacy of NVG-2089 in ...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 ...
NVG-2089 / Nuvig TherapeuticsSafety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Nuvig ...
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