At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 24 target
Drug / intervention
Budoprutugdrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age 18 years or older at consent
- ✓Platelet count <30,000/µL confirmed on 2 occasions 5-14 days apart despite prior therapeutic attempt
- ✓Coagulation parameters within acceptable limits
Key exclusion· 9
- ✕CD19+ B cell count <80 cells/µL at screening (or <40 cells/µL if prior B-cell depleting therapy within 24 weeks to 2 years)
- ✕Diagnosis of paroxysmal nocturnal hemoglobinuria, Evans Syndrome, or other bleeding disorders affecting safety or data integrity
- ✕Prior B-cell depleting therapy within 24 weeks before first dose
- ✕Chronic anticoagulants or antiplatelet agents within 14 days before dosing through follow-up
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)
In Brief
A Phase 2 clinical trial evaluating Budoprutug for Immune Thrombocytopenia (ITP) and 4 related conditions. Currently recruiting, targeting 24 participants across 20 sites in 5 countries.
Signals
Enrolling ahead of pace
Detailed Summary
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal, Anti-CD19
CountriesBulgaria, Greece, Serbia, Spain, Ukraine
Collaborators--
Timeline
Phase 2Recruiting
202620272028
First PostedJun 2025
Enrollment StartJun 2025
TodayJul 2026
Primary CompletionAug 2027
Study CompletionAug 2028
First PostedJun 29, 2025
Enrollment StartJun 30, 2025
Primary CompletionAug 1, 2027
Study CompletionAug 1, 2028
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 1.0 years agoPrimary completion in 1.1 years
Interventions
Budoprutugdrug
Single IV dose of study product on Day 1 and Day 15