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A study to find how well budoprutug (TNT119) works and how safe it is in participants with immune thrombocytopenia
EU CTIS ID: 2024-519745-30-00
What this study is testing
To evaluate the safety and tolerability of ascending doses of budoprutug in subjects with ITP.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Aged > 18 years at the time of informed consent.
- 2. Platelet count < 30,000/μL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of < 30,000/μL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.
- 3. Partial thromboplastin time < 1.5 × upper limit of normal (ULN), prothrombin time < 1.5 × ULN, total bilirubin < 1.5 × ULN unless due to Gilbert’s syndrome, or an international normalized ratio < 1.5 at screening.
- 4. Adequate hematologic, hepatic, and renal function
- 5. If being treated with corticosteroids or thrombopoietin (TPO) agonists, subjects must be on a stable dose (< 20% change in dose over the 14 days prior to the first dose of study drug). Corticosteroid treatment should not be > 1 mg/kg methylprednisolone (or equivalent) for 2 weeks prior to the first dose of study drug.
- 6. Diagnosed with primary ITP
You likely can't join if
- 1. CD19+ B-cell count < 80 cells/μL at Screening or < 40 cells/μL if B-cell depleting treatment was received within 24 weeks to 2 years prior to Screening.
- 2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan’s Syndrome, or any other bleeding disorder that could confound results and impact patient safety.
- 3. Prior treatment with rituximab or other B-cell depleting agents within 24 weeks prior to the first dose of study drug or plan to receive B-cell depleting agents during the study.
- 4. Current or planned treatment with any chronic anticoagulants or platelet aggregation-inhibiting drugs such as aspirin, nonsteroidal anti-inflammatory drugs, or thienopyridines within 14 days of planned dosing through the end of follow-up. Symptom-based intermittent dosing of nonsteroidal anti-inflammatory drugs is permitted.
- 5. Prior treatment with immunosuppressants (other than corticosteroids) within 30 days or 5 times the elimination half-life (whichever is longer) of the Screening Visit (e.g., calcineurin inhibitors, mycophenolate mofetil, azathioprine), or alkylating agents within 180 days of the Screening Visit.
- 6. Active or uncontrolled infection at the time of informed consent or study drug initiation.
See the full eligibility criteria
Who can join
- 1. Aged > 18 years at the time of informed consent.
- 2. Platelet count < 30,000/μL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of < 30,000/μL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.
- 3. Partial thromboplastin time < 1.5 × upper limit of normal (ULN), prothrombin time < 1.5 × ULN, total bilirubin < 1.5 × ULN unless due to Gilbert’s syndrome, or an international normalized ratio < 1.5 at screening.
- 4. Adequate hematologic, hepatic, and renal function
- 5. If being treated with corticosteroids or thrombopoietin (TPO) agonists, subjects must be on a stable dose (< 20% change in dose over the 14 days prior to the first dose of study drug). Corticosteroid treatment should not be > 1 mg/kg methylprednisolone (or equivalent) for 2 weeks prior to the first dose of study drug.
- 6. Diagnosed with primary ITP
What rules you out
- 1. CD19+ B-cell count < 80 cells/μL at Screening or < 40 cells/μL if B-cell depleting treatment was received within 24 weeks to 2 years prior to Screening.
- 2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan’s Syndrome, or any other bleeding disorder that could confound results and impact patient safety.
- 3. Prior treatment with rituximab or other B-cell depleting agents within 24 weeks prior to the first dose of study drug or plan to receive B-cell depleting agents during the study.
- 4. Current or planned treatment with any chronic anticoagulants or platelet aggregation-inhibiting drugs such as aspirin, nonsteroidal anti-inflammatory drugs, or thienopyridines within 14 days of planned dosing through the end of follow-up. Symptom-based intermittent dosing of nonsteroidal anti-inflammatory drugs is permitted.
- 5. Prior treatment with immunosuppressants (other than corticosteroids) within 30 days or 5 times the elimination half-life (whichever is longer) of the Screening Visit (e.g., calcineurin inhibitors, mycophenolate mofetil, azathioprine), or alkylating agents within 180 days of the Screening Visit.
- 6. Active or uncontrolled infection at the time of informed consent or study drug initiation.
- 7. Recent hospitalization for any reason within 14 days prior to Screening, unless approved by the Medical Monitor.
- 8. Receipt of a live vaccine within 28 days prior to the first dose of study drug or during the study. All other vaccines must be completed within 21 days prior to the first dose of study drug.
- 9. Secondary cause of ITP (e.g., malignancy, hepatitis B or C, HIV, or other autoimmune diseases [e.g., thyroiditis], or drug-induced ITP).
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- United Kingdom
- Ukraine
- United States
- Serbia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; United Kingdom; Ukraine; United States; Serbia. 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 EU CTIS; the study team decides eligibility.