Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07043946 | A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP) | PHASE1 | RECRUITING | 24 | — | — | Jun 30, 2025 | Aug 1, 2028 | Mar 27, 2026 | 20 | Bulgaria, Greece +3 |
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose Level A | EXPERIMENTAL | Single IV dose of study product on Day 1 and on Day 15 |
| Cohort 2: Dose Level B | EXPERIMENTAL | Single IV dose of study product on Day 1 and on Day 15 |
| Cohort 3: Dose Level C | EXPERIMENTAL | Single IV dose of study product on Day 1 and on Day 15 |
| Dose Expansion Cohort | EXPERIMENTAL | Single IV dose of study product on Day 1 and Day 15 |
| Name | Type | Description |
|---|---|---|
| Budoprutug | DRUG | Single IV dose of study product on Day 1 and Day 15 |
Inclusion Criteria: 1. Aged 18 years at the time of 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 thrombo...