NVG-2089 for Immune thrombocytopenia (ITP) | Primary immune thrombocytopenia

Inclusion criteria

• {"criterion_text":"-1. Male and female participants, age 18 to 80 years at time of screening.\n-2. 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).\n-3. Asymptomatic or with minor mucocutaneous bleeding AND platelet count of ≥20,000 to <50,000 cells/mm3, measured on 2 occasions. At least one measurement should be obtained during screening. Documented historical platelet count obtained within 4 weeks prior to screening will also be acceptable for one of the two readings.\n-5. If participant has received prior IVIg therapy participant must have shown a sufficient platelet response (doubling of platelet count within 7 days of IVIg infusion) and must not have lost response to IVIg therapy while on treatment.\n-6. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1.\n-7. 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.\n-8. 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.\n-9. 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."}

Exclusion criteria

• {"criterion_text":"-1. Secondary forms of ITP (e.g., ITP secondary to infection, autoimmune diseases, lymphoproliferative diseases and medications)\n-10. Any of the following at screening: a. Active Hepatitis B Virus (HBV): Hepatitis surface antigen (HBsAg) positive b. Active Hepatitis C Virus (HCV): serology positive for HCV-antibody c. Human Immunodeficiency Virus (HIV) positive serology\"\n-11. Transfusion of blood, blood products (including immune globulin), or plasmapheresis within 4 weeks prior to screening.\n-12. 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.\n-13. Receipt of dexamethasone within 4 weeks prior to screening.\n-14. Receipt of rituximab or an anti-CD20 agent within 6 months prior to screening.\n-15. Receipt of an neonatal Fc receptor (FcRn) inhibitor within 12 weeks prior to screening.\n-16. Receipt of IVIg within 4 weeks prior to screening.\n-17. Receipt of anticoagulants within 4 weeks prior to screening\n-18. Receipt of another investigational drug within 4-weeks or 5 half-lives (whichever is longer) prior to screening.\n-19. Concurrent treatment with other monoclonal antibody and/or Fc therapies.\n-2. History of splenectomy.\n-20. Current or past history (within 12 months of screening) of alcohol, drug, or medication abuse. Positive urine drug screen at screening visit.\n-21. 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.\n-22. Poor venous access.\n-23. A known allergy to study drug and/or any of its components.\n-3. History of malignancy, unless the participant received treatment with curative intent. Participants with fully excised non-melanoma skin cancer or cervical cancer are allowed.\n-4. History of solid organ transplant or hematopoietic stem cell transplantation.\n-5. Planned or anticipated medical or surgical procedure, including dental procedure, during the timeframe of study conduct.\n-6. Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening, including active viral infection at screening.\n-7. 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.\n-8. ECG findings of QTcF > 450 msec (males) or > 470 msec (females), poorly controlled atrial fibrillation or other clinically significant abnormalities.\n-9. Other significant organ dysfunction, including but not limited to, hematologic, renal, or hepatic dysfunction, as evidenced by: a. Absolute neutrophil count ≤ 1.5 x 10^9/L b. Hemoglobin (Hgb) < 9 g/dL c. Aspartate aminotransaminase (AST) and/or alanine aminotransferase (ALT) ≥ 2 x the upper limit of normal (ULN), d. Albumin ≤ 3 g/dL e. Total bilirubin ≥ 1.5 x ULN f. Estimated glomerular filtration rate < 50 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method"}

Primary endpoints

• {"endpoint_text":"-Incidence, nature, and severity of TEAEs, and serious adverse events (SAEs)","definition_or_measurement_approach":"Assessment of incidence, nature and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as recorded during the study."}

Secondary endpoints

• {"endpoint_text":"-1. Percent of participants achieving a response. − For participants with a dose-specific baseline platelet count <30,000 cells/mm3, a response is defined as a doubling of the dose-specific baseline platelet count or a platelet count of ≥50,000 cells/mm3; − For participants with a dose-specific baseline platelet count ≥30,000 cells/mm3, a response is defined as an increase in the platelet count to >20,000 cells/ mm3 from dose-specific baseline or a platelet count of ≥80,000 cells/mm3","definition_or_measurement_approach":"Response definitions provided in the endpoint: dose-specific baseline platelet counts are used; specific thresholds described for <30,000 and ≥30,000 baseline strata."}
• {"endpoint_text":"-2. Duration of response","definition_or_measurement_approach":"Duration of response as defined for responders (no additional explicit measurement approach provided in the record)."}
• {"endpoint_text":"-3. Absolute and percent change from the dose-specific baseline in platelet count Note: Dose-specific baseline for response analysis is defined as predose platelet count on each dosing day.","definition_or_measurement_approach":"Absolute and percent change from dose-specific baseline platelet count; dose-specific baseline is defined as predose platelet count on each dosing day."}
• {"endpoint_text":"-4. PK parameters of NVG-2089","definition_or_measurement_approach":"Pharmacokinetic parameters of NVG-2089 (PK sampling and parameter estimation implied; no further detail in JSON)."}

Poland

Earliest CTIS Part Ii Submission Date

10-07-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

39

Number Of Sites

2

Number Of Participants

10

Greece

Earliest CTIS Part Ii Submission Date

14-05-2025

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

92

Number Of Sites

3

Number Of Participants

3

Spain

Earliest CTIS Part Ii Submission Date

02-06-2025

Latest Decision Or Authorization Date

12-08-2025

Processing Time Days

71

Number Of Sites

6

Number Of Participants

12

Primary sponsor

Full Name

Nuvig Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

Sponsor duties codes: 1, 11, 12, 13, 15 (Adjudication; Equipment Provision), 2, 5, 8

Name

PPD Global Ltd.

Responsibilities

Project management duties and monitoring/regulatory

Name

Pharpoint Research Inc.

Responsibilities

Sponsor duties codes: 10, 6, 7

Name

Meeting Protocol Worldwide LP

Responsibilities

Investigator Meeting Planned; Subject Stipend/Travel Reimbursement

Third parties

• {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"Investigator Meeting Planned; Subject Stipend/Travel Reimbursement (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Sponsor duties codes: 1, 11, 12, 13, 15 (Adjudication; Equipment Provision), 2, 5, 8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Packaging Coordinators LLC","duties_or_roles":"Sponsor duties code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Project management duties and monitoring/regulatory (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Pharpoint Research Inc.","duties_or_roles":"Sponsor duties codes: 10, 6, 7","organisation_type":"Pharmaceutical company"}