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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05398653 | A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy | PHASE1 | COMPLETED | 94 | — | — | Feb 24, 2022 | Apr 18, 2025 | Nov 17, 2025 | 1 | China |
Evaluation of the Tolerability and Safety of MIL62 in Participants with pMN.The tolerance is defined as the occurrence of CTCAE 5.0 Grade ≥3 adverse events within 28 days after the first dose of MIL62.Safety assessments included adverse events, vital signs, physical examinations, laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status and 12-lead electrocardiograms (ECG) during the study period.
The proportion of participants who achieved immune remission(Anti-PLA2R antibody\<14RU/mL) at week 12.
The proportion of participants who achieved overall remission (complete and partial remission) at week 24.
| Arm | Type | Description |
|---|---|---|
| MIL62(600mg) | EXPERIMENTAL | - |
| Ciclosporin | ACTIVE_COMPARATOR | - |
| MIL62(1000mg) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MIL62 | DRUG | A 600 mg intravenous (IV) infusion of MIL62 will be administered on Week 1 Day 1 and Week 3 Day 1. If treatment response is observed, additional doses will be administered on Week 25 Day 1 and Week 27 Day 1. According to the protocol amendment in June 2023, some patients also received MIL62 treatment on Week 53 Day 1. |
| Cyclosporine | DRUG | Participants will receive Cyclosporine at a starting oral dose 3.5 mg/kg/d, divided into 2 doses, try to give every 12 hours. The dose was adjusted according to the blood concentration of cyclosporine monitored every 2 weeks ±3 days until the target blood concentration of 125\~175 ng/ mL was reached. Optimized cyclosporine dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. |
Inclusion Criteria: 1. Adult patients, ≥18 years of age; 2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening； 3. Screening 24-hour urinary protein \>= 5 g after best supportive care for \>= 3 months prior to screening or screening 24-hour urin...