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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04925934 | Study of VIB7734 for the Treatment of Moderate to Severely Active SLE | PHASE2 | COMPLETED | 214 | — | — | May 28, 2021 | Jun 9, 2023 | Jul 23, 2024 | 67 | United States, Argentina +9 |
A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.
| Arm | Type | Description |
|---|---|---|
| VIB7734 SC (dosing interval 1) | EXPERIMENTAL | - |
| VIB7734 SC (dosing interval 2) | EXPERIMENTAL | - |
| Placebo SC (dosing interval 3) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VIB7734 | DRUG | VIB7734 |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Age ≥ 18 years to ≤ 70 years * Willing and able to understand and provide written informed consent. * Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE * Disease duration of at least 6 months * Active SLE as in...