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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07213960 | A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis | PHASE2 | NOT YET_RECRUITING | 270 | — | — | Dec 1, 2025 | Dec 1, 2029 | Oct 9, 2025 | 2 | United States |
Change from Baseline in Log-Transformed uPCR will be based on triplicate first morning urine (FMU)
Change from baseline in log-transformed uPCR will be based on triplicate first morning urine (FMU)
| Arm | Type | Description |
|---|---|---|
| Phase 2 - APL2 | EXPERIMENTAL | Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly |
| Phase 3 - APL2 | EXPERIMENTAL | Adults: Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly Adolescents: ≥50 Kg: Sub-cutaneous infusions of APL2 (1080 mg / 20mL) twice weekly 35 to \<50kg: First sub-cutaneous infusion of 648mg (12 mL) followed by 810mg (15 mL) every infusion thereafter (i.e. twice weekly) 30 to \<35kg: First \& Second sub-cutaneous infusion of 540mg (10mL) followed by 648mg (12 mL) every infusion thereafter (twice weekly) |
| Phase 3 - Placebo | PLACEBO_COMPARATOR | Subcutaneous infusions of a sterile solution, twice-weekly, and equivalent in volume to the active arm based on participant's age and weight |
| Name | Type | Description |
|---|---|---|
| APL2 | DRUG | Complement (C3) Inhibitor |
| Placebo | OTHER | Sterile solution of equal volume to active arm |
Inclusion Criteria: * Age * Phase 2: adults aged ≥18 years * Phase 3: adults aged ≥18 years; if and where approved, adolescents (aged 12--17 years) at the time of signing the informed consent and assent form * Weight ≥30 kg and ≤100 kg at screening * FSGS diagnosis * Phase 2: primary, genet...