| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03597464 | Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin | PHASE3 | COMPLETED | 216 | — | — | Sep 29, 2019 | Oct 7, 2021 | Dec 14, 2022 | 1 | United States |
| NCT03021499 | Aurinia Renal Response in Active Lupus With Voclosporin | PHASE3 | COMPLETED | 358 | — | — | May 17, 2017 | Oct 10, 2019 | Mar 27, 2023 | 185 | United States, Argentina +29 |
| NCT02949973 | Aurinia Early Urinary Protein Reduction Predicts Response | PHASE2 | COMPLETED | 10 | — | — | Jun 1, 2015 | Feb 17, 2017 | Mar 19, 2021 | 2 | Malaysia |
| NCT02141672 | AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV) | PHASE2 | COMPLETED | 265 | — | — | Jun 1, 2014 | Jan 1, 2017 | May 18, 2021 | 86 | United States, Bangladesh +18 |
Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN.
The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria * UPCR of ≤0.5 mg/mg \& * eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20% \& * Received no rescue medication for LN \& * Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR \<60 mL/min/1.73 m2 \& confirmed \>20% drop from baseline) \& have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response
Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.
| Arm | Type | Description |
|---|---|---|
| Voclosporin | EXPERIMENTAL | Voclosporin |
| Placebo Oral Capsule | PLACEBO_COMPARATOR | Placebo |
| Voclosporin Low Dose | EXPERIMENTAL | Voclosporin, oral, 23.7 mg BID |
| Voclosporin High Dose | EXPERIMENTAL | Voclosporin, oral 23.7 mg BID until Week 2, then voclosporin, oral, 39.5 mg BID |
| Placebo | PLACEBO_COMPARATOR | Low dose: Voclosporin placebo, oral, 3 capsules BID High dose: Voclosporin placebo, oral, 3 capsules BID until Week 2 then voclosporin placebo, oral, 5 capsules BID |
| Name | Type | Description |
|---|---|---|
| Voclosporin | DRUG | Calcineurin inhibitor, oral, 23.7 mg twice daily (BID) |
| Placebo Oral Capsule | DRUG | Voclosporin placebo, oral, 3 capsules twice daily (BID) |
| Voclosporin High Dose | DRUG | - |
| Voclosporin Low Dose | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval. 2. Written informed consent before...