Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
voclosporin · 11 trials · 6 indications
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
Proportion of subjects achieving a PASI-75 at 12 weeks at each of the 3 dose levels of voclosporin.
Drop Discomfort was assessed using the Individual Symptom Severity Assessment Visual Analog Scale (VAS) where the subject will complete the assessment 1 minute post-instillation on Day 1. The VAS scale is 0 - 100, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort".
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.
The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.
To evaluate the potential effect of multiple oral doses of voclosporin on the single-dose PK of simvastatin and the active metabolite simvastatin acid. Maximum observed concentration (Cmax).
To evaluate the potential effect of multiple oral doses of voclosporin on the single-dose PK of simvastatin and the active metabolite simvastatin acid. Area under the concentration-time curve (AUC) from time zero to infinity.
Tolerability of voclosporin after single and multiple oral ascending doses
Safety of voclosporin after single and multiple oral ascending doses
| Arm | Type | Description |
|---|---|---|
| Voclosporin | EXPERIMENTAL | Voclosporin |
| Placebo Oral Capsule | PLACEBO_COMPARATOR | Placebo |
| 1. | ACTIVE_COMPARATOR | - |
| 3. | PLACEBO_COMPARATOR | - |
| 2. | ACTIVE_COMPARATOR | - |
| 1 | ACTIVE_COMPARATOR | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| Placebo Comparator: 1 | PLACEBO_COMPARATOR | Placebo |
| Voclosporin 0.2 mg/kg po BID | ACTIVE_COMPARATOR | Voclosporin 0.2 mg/kg po BID |
| Voclosporin 0.3 mg/kg po BID | ACTIVE_COMPARATOR | Voclosporin 0.3 mg/kg po BID |
| Voclosporin 0.4 mg/kg po BID | ACTIVE_COMPARATOR | Voclosporin 0.4 mg/kg po BID |
| Voclosporin ophthalmic solution (VOS) | EXPERIMENTAL | 0.2% VOS, Twice Daily (BID), both eyes for 28 days |
| Comparator | ACTIVE_COMPARATOR | 0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days |
| 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 |
| Low Dose Voclosporin | ACTIVE_COMPARATOR | Low dose voclosporin |
| Mid Dose Voclosporin | ACTIVE_COMPARATOR | Mid Dose Voclosporin |
| High Dose Voclosporin | ACTIVE_COMPARATOR | High Dose Voclosporin |
| Tacrolimus | ACTIVE_COMPARATOR | Standard Dose Tacrolimus |
| Voclosporin/Simvastatin | EXPERIMENTAL | Subjects will receive a single oral dose of 40 mg simvastatin (given as two 20 mg tablets) in the morning of Day 1 and Day 8. Subjects will receive voclosporin administered as an oral 23.7 mg dose (three 7.9 mg capsules) twice-daily for 7 days from the morning of Day 2 until the evening of Day 8. |
| 0.25mg/kg voclosporin | EXPERIMENTAL | 0.25mg/kg voclosporin BID. |
| 0.5mg/kg voclosporin | EXPERIMENTAL | 0.5mg/kg voclosporin BID |
| 1.0mg/kg voclosporin | EXPERIMENTAL | 1.0mg/kg voclosporin BID |
| 1.5mg/kg voclosporin | EXPERIMENTAL | 1.5mg/kg voclosporin BID |
| Placebo voclosporin | PLACEBO_COMPARATOR | placebo 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) |
| Ciclosporin | DRUG | ciclosporin 1.5 mg/kg po BID |
| Placebo | DRUG | Placebo |
| Voclosporin Ophthalmic Solution | DRUG | Investigational Drug |
| Restasis® | DRUG | Comparator |
| Voclosporin High Dose | DRUG | - |
| Voclosporin Low Dose | DRUG | - |
| tacrolimus | DRUG | tacrolimus 0.05 mg/kg po BID |
| Simvastatin | DRUG | Oral dose 40 mg |
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...
Voclosporin is an investigational small molecule being studied for kidney diseases, lupus nephritis, dry eye, and psoriasis. It has also been evaluated in healthy volunteers for drug-drug interaction studies. The drug is developed by Aurinia Pharmaceuticals Inc (AUPH) and is currently in clinical development, with completed trials in these indications.
Voclosporin is a calcineurin inhibitor, a type of immunosuppressant that works by blocking the activity of calcineurin, an enzyme involved in activating T-cells of the immune system. By inhibiting this pathway, voclosporin aims to reduce the immune response that contributes to conditions like lupus nephritis and other inflammatory diseases.
Voclosporin is developed by Aurinia Pharmaceuticals Inc, a biopharmaceutical company traded under the ticker symbol AUPH. The company is conducting clinical trials to evaluate the drug for multiple indications, including lupus nephritis and dry eye disease.
Voclosporin is in Phase 1 clinical development, according to the latest data. It has completed four clinical trials, including Phase 1 and Phase 2 studies, but no active trials are currently listed. The drug remains investigational and has not been approved by regulatory authorities.
Voclosporin has completed four clinical trials. These include NCT00270634, a Phase 2 study in de novo renal transplantation for kidney diseases; NCT02949973, a Phase 2 study in lupus nephritis; NCT03597139, a Phase 2 study in dry eye disease; and NCT05306379, a Phase 1 drug-drug interaction study with simvastatin.
Yes, voclosporin is also known as ISA247. In clinical trials, it has been referred to by this alternative name, such as in the study 'Study of ISA247 (Voclosporin) in De Novo Renal Transplantation' (NCT00270634). This helps identify the drug across different research contexts.