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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05126277 | Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | PHASE3 | ACTIVE NOT_RECRUITING | 452 | — | — | Jul 14, 2022 | Feb 11, 2031 | May 22, 2026 | 156 | United States, Argentina +25 |
The primary objective is to demonstrate superiority of ianalumab compared to placebo, in achieving stable CRR (defined as estimated glomerular filtration rate (eGFR) ≥90 ml/min/1.73 m2 or no less than 85% of baseline, AND, 24-hour UPCR \<0.5 g/g) at Week 72 in active lupus nephritis (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous) participants on background SoC therapy.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - ianalumab s.c. q4w | EXPERIMENTAL | ianalumab s.c. q4w in addition to standard of care (SoC) |
| Arm 2 - ianalumab s.c. q12w | EXPERIMENTAL | ianalumab s.c. q12w in addition to SoC |
| Arm 3 - placebo s.c. q4w | PLACEBO_COMPARATOR | Placebo s.c. q4w in addition to SoC |
| Name | Type | Description |
|---|---|---|
| ianalumab s.c. q4w | DRUG | ianalumab s.c. q4w in addition to SoC |
| ianalumab s.c. q12w | DRUG | ianalumab s.c. q12w in addition to SoC |
| placebo s.c. | DRUG | placebo s.c. q4w in addition to SoC |
Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: * Adult male and female participants aged 18 years or older at the time of screening * Weigh at least 35 kg at screening * Have a confirmed clinical diagnosis of SLE according to European...