Recent Updates
Recently added Catalysts

voclosporin

Phase 3

Lupus Nephritis | Small molecule | Immunology |Aurinia Pharmaceuticals Inc|Last Updated: Mar 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment849
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03597464Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With VoclosporinPHASE3 COMPLETED 216Sep 29, 2019Oct 7, 2021Dec 14, 20221 United States
NCT03021499Aurinia Renal Response in Active Lupus With VoclosporinPHASE3 COMPLETED 358May 17, 2017Oct 10, 2019Mar 27, 2023185 United States, Argentina +29
NCT02949973Aurinia Early Urinary Protein Reduction Predicts ResponsePHASE2 COMPLETED 10Jun 1, 2015Feb 17, 2017Mar 19, 20212 Malaysia
NCT02141672AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)PHASE2 COMPLETED 265Jun 1, 2014Jan 1, 2017May 18, 202186 United States, Bangladesh +18
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.
Month 12 (AURORA 2 baseline) to Month 36

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.

Number of Participants With Adjudicated Renal Response at Week 52
52 Weeks

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

Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR)
24 weeks
Number of Participants With Reduction or Normalization of Anti ds DNA
24 weeks
Number of Participants With Reduction or Normalization of C3
24 weeks
Number of Participants With Reduction or Normalization of C4
24 weeks
Number of Subjects Achieving Complete Renal Remission at 24 Weeks
week 24

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.

Secondary Endpoints
Number (and Percent) of Subjects in Renal Response
Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36
Number (and Percent) of Subjects in Partial Renal Response
Months 12 (AURORA 2 baseline), 18, 24, 30 and 36
Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC).
Month 12 (AURORA 2 baseline) to Month 36
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VoclosporinEXPERIMENTALVoclosporin
Placebo Oral CapsulePLACEBO_COMPARATORPlacebo
Voclosporin Low DoseEXPERIMENTALVoclosporin, oral, 23.7 mg BID
Voclosporin High DoseEXPERIMENTALVoclosporin, oral 23.7 mg BID until Week 2, then voclosporin, oral, 39.5 mg BID
PlaceboPLACEBO_COMPARATORLow 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
Interventions
NameTypeDescription
VoclosporinDRUGCalcineurin inhibitor, oral, 23.7 mg twice daily (BID)
Placebo Oral CapsuleDRUGVoclosporin placebo, oral, 3 capsules twice daily (BID)
Voclosporin High DoseDRUG -
Voclosporin Low DoseDRUG -
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United StatesArgentinaBelarusBrazilBulgariaCanadaChileColombiaCosta RicaCroatiaDominican RepublicGuatemalaJapanMalaysiaMexicoNetherlandsNorth MacedoniaPeruPhilippinesPolandPuerto RicoRussiaSerbiaSouth AfricaSouth KoreaSpainTaiwanThailandTurkey (Türkiye)UkraineVietnamBangladeshChinaEcuadorGeorgiaSingaporeSri Lanka
Unlock Eligibility Criteria