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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07474636 | Efficacy and Safety Study of HS-10542 for IgA Nephropathy | PHASE2 | NOT YET_RECRUITING | 90 | — | — | Mar 17, 2026 | Jan 30, 2028 | Mar 16, 2026 | 1 | China |
The change of UPCR from baseline
| Arm | Type | Description |
|---|---|---|
| HS-10542 High Dose Arm | EXPERIMENTAL | Experimental: HS-10542 High Dose, QD |
| HS-10542 Low Dose Arm | EXPERIMENTAL | Experimental: HS-10542 Low Dose, QD |
| Placebo Arm | PLACEBO_COMPARATOR | Placebo Comparator: Placebo，QD |
| Name | Type | Description |
|---|---|---|
| HS-10542 High Dose | DRUG | Drug: HS-10542 High Dose, QD |
| HS-10542 Low Dose | DRUG | Drug: HS-10542 Low Dose, QD |
| Placebo | DRUG | Placebo, QD |
Inclusion Criteria: 1. Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent. 2. Body weight≥35kg, BMI\<37.5kg/m2. 3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years. 4. 24-hour urine protein excretion≥1.0g/24h, or UPCR≥0.8g/g ...