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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05029635 | Phase III Study on HMPL-523 for Treatment of ITP | PHASE3 | COMPLETED | 272 | — | — | Oct 27, 2021 | Sep 18, 2025 | May 4, 2026 | 37 | China |
Platelet count ≥50×10\^9 /L on at least 4 of 6 scheduled visits of Week14-Week24 in the primary study
| Arm | Type | Description |
|---|---|---|
| Drug: HMPL-523 | ACTIVE_COMPARATOR | Primacy study (Randomized, Double-Blind Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 24 weeks. Sub study (Open-label Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 76 weeks after the enrollment of the last patient enrolled in open-label phase. |
| Drug: placebo | PLACEBO_COMPARATOR | Primacy study (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| HMPL-523 | DRUG | HMPL-523(300mg PO QD) |
| Placebo | DRUG | Placebo(300mg PO QD) |
Inclusion Criteria for double-blind phase: 1. Voluntary signature of written informed consent form; 2. Male or female aged 18\~75 years; 3. Performance Status score \[Eastern Cooperative Oncology Group (ECOG) score\] 0\~1; 4. Having been diagnosed as ITP prior to randomization, and duration of dise...