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Tests treatment safety and results for Immune Thrombocytopenia (ITP)
Official title Safety, Tolerability, and Efficacy of NVG-2089 in Participants With Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT07095127
What this study is testing
What is NVG-2089?
NVG-2089 is an investigational medicine, being studied as a potential treatment for immune thrombocytopenia (itp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- (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...
- If participant has received prior IVIg therapy participant must have shown a sufficient platelet response (doubling from baseline platelet count...
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1.
- 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...
- 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.
What rules you out
- 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:
- 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...
- Poor venous access.
- A known allergy to study drug and/or any of its components.
The study team makes the final eligibility decision.
Where it's taking place
- Greenville, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greenville, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.