Immune Thrombocytopenia (ITP)Phase 2NCT07095127
Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia
A Phase 2 study testing NVG-2089 in people with Immune Thrombocytopenia (ITP), run by Nuvig Therapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- NVG-2089
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 apart during the screening period.
- (For US only) If at least one screening platelet count >30,000 cells/ mm3 and <50,000 cells/mm3, the participant must be on at least 1 other treatment for ITP with insufficient response as evidenced by platelet count <50,000 cells/ mm3.
- If participant has received prior IVIg therapy participant must have shown a sufficient platelet response (doubling from baseline platelet count within 7 days of IVIg infusion) and must not have lost response to IVIg therapy while on treatment.
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1.
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- Female participants who are sexually active with a male partner of reproductive potential must use double contraception (including a barrier contraceptive and another method) from at least 28 days prior to Screening and for 90 days after last dose of study drug; female participants must also refrain from oocyte donation for the purpose of reproduction during this period. Exceptions are made for surgically sterile participants, or post-menopausal females (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle -stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy). Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- Male participants with female partners who are of reproductive potential must agree to the use of highly effective, barrier contraception for the duration of the study, and for 90 days after the last dose of study drug.
- Participant is capable or has a legally authorized representative(s) (LAR[s]) capable of providing a signed informed consent which includes compliance with the requirements and restrictions listed in the ICF.
Who cannot join
- 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.
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- 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:
- Absolute neutrophil count ≤ 1.5 x 109 /L
- Hemoglobin (Hgb) < 9 g/dL
- Aspartate aminotransaminase (AST) and/or alanine aminotransferase (ALT) ≥ 2 x the upper limit of normal (ULN),
- Albumin ≤ 3 g/dL
- Total bilirubin ≥ 1.5 x ULN
- Estimated glomerular filtration rate < 50 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method
- Any of the following at screening:
- Active Hepatitis B Virus (HBV): Hepatitis surface antigen (HBsAg) positive
- Active Hepatitis C Virus (HCV): serology positive for HCV-antibody
- Human Immunodeficiency Virus (HIV) positive serology
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rushad Patell, MD, 617-667-2100, rpatell@bidmc.harvard.edu
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Sue Ann Joyner Joyner, 252-744-9010, joynersu@ecu.edu
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Jennifer Steffen, 202-687-3044, js4936@georgetown.edu
About this study
Official title: An Open-Label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants With Immune Thrombocytopenia
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
- Immune Thrombocytopenia (ITP)
- Being tested
- NVG-2089
- Keywords
- Immune Thrombocytopenia, ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVG-2089Drug
Study Treatment
| Study group | Role | What they receive |
|---|---|---|
| NVG-2089 | Experimental | NVG-2089 Receives: Drug: NVG-2089 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate incidence, nature and severity of Treatment Emergent Adverse Events (TEAEs)
Measured: From enrollment to end of treatment Week 20
Evaluate incidence, nature and severity of Serious Adverse Events (SAEs)
Measured: From enrollment to end of treatment Week 20
Secondary outcomes (1)
Percent of participants achieving a response.
- For participants with a baseline platelet count between < 30,000 cells/mm3, a response is defined as a doubling of the baseline platelet count or a platelet count of ≥50,000 cells/mm3;
- For participants with a baseline platelet count ≥ 30,000 t cell/mm3, a response is defined as an increase in the baseline platelet count to >20,000 cells/mm3;
Measured: From enrollment to Treatment Completion up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start30 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvig Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095127
- Sponsor's protocol ID
- NVG-2089-200
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07095127
- Acronym / sponsor ID
- NVG-2089-200
- Conditions
- Immune Thrombocytopenia (ITP)
- Keywords
- Immune Thrombocytopenia, ITP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nuvig Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVG-2089 | Experimental | Drug: NVG-2089NVG-2089 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 apart during the screening period.
- (For US only) If at least one screening platelet count >30,000 cells/ mm3 and <50,000 cells/mm3, the participant must be on at least 1 other treatment for ITP with insufficient response as evidenced by platelet count <50,000 cells/ mm3.
- If participant has received prior IVIg therapy participant must have shown a sufficient platelet response (doubling from baseline platelet count within 7 days of IVIg infusion) and must not have lost response to IVIg therapy while on treatment.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVG-2089Study Treatment | Drug | NVG-2089 |
Primary outcome
Evaluate incidence, nature and severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: From enrollment to end of treatment Week 20
Evaluate incidence, nature and severity of Serious Adverse Events (SAEs)
Time frame: From enrollment to end of treatment Week 20
1 secondary outcome
Percent of participants achieving a response.
Time frame: From enrollment to Treatment Completion up to Week 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVG-2089 in people with Immune Thrombocytopenia (ITP), run by Nuvig Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuvig Clinical Trials (650 292-2184, clinicaltrials@nuvigtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate incidence, nature and severity of Treatment Emergent Adverse Events (TEAEs) (time frame: From enrollment to end of treatment Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.