Trial Outcomes & Findings for Aurinia Renal Response in Active Lupus With Voclosporin (NCT NCT03021499)

Last Updated: 2023-03-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

358 participants

Primary outcome timeframe

52 Weeks

Results posted on

2023-03-27

Participant Flow

Eligible subjects were randomized in a ratio of 1:1 to receive either voclosporin 23.7 mg twice daily (BID) or matching placebo for 52 weeks. All subjects were also to receive 2 g/day mycophenolate mofetil (MMF). In addition, all subjects were to receive 0.5 g/day intravenous (IV) methylprednisolone on Days 1 and 2 before changing to a reducing course of oral corticosteroid therapy on Day 3.

Participant milestones

Participant milestones
Measure	Voclosporin Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid	Placebo Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
Overall Study STARTED	179	178
Overall Study Week 24	167	162
Overall Study Week 52	162	147
Overall Study COMPLETED	163	147
Overall Study NOT COMPLETED	16	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Voclosporin Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid	Placebo Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
Overall Study Adverse Event	1	0
Overall Study Death	1	5
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	1	3
Overall Study Physician Decision	2	3
Overall Study Pregnancy	1	0
Overall Study Withdrawal by Subject	7	14
Overall Study Prohibited medication required	1	0
Overall Study Protocol non-compliance	1	1
Overall Study None of the above	0	4
Overall Study Adverse Event (AE) Prior to First Dose	1	0

Baseline Characteristics

Aurinia Renal Response in Active Lupus With Voclosporin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo: matching placebo capsule	Total n=357 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 10.93 • n=93 Participants	33.6 years STANDARD_DEVIATION 11 • n=4 Participants	33.2 years STANDARD_DEVIATION 10.96 • n=27 Participants
Sex: Female, Male Female	161 Participants n=93 Participants	152 Participants n=4 Participants	313 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	26 Participants n=4 Participants	44 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	57 Participants n=93 Participants	59 Participants n=4 Participants	116 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	122 Participants n=93 Participants	118 Participants n=4 Participants	240 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Asian	53 Participants n=93 Participants	56 Participants n=4 Participants	109 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	21 Participants n=93 Participants	13 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) White	68 Participants n=93 Participants	61 Participants n=4 Participants	129 Participants n=27 Participants
Race (NIH/OMB) More than one race	37 Participants n=93 Participants	44 Participants n=4 Participants	81 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	26 participants n=93 Participants	26 participants n=4 Participants	52 participants n=27 Participants
Region of Enrollment Southeast Asia	52 participants n=93 Participants	52 participants n=4 Participants	104 participants n=27 Participants
Region of Enrollment Europe	52 participants n=93 Participants	52 participants n=4 Participants	104 participants n=27 Participants
Region of Enrollment South America	49 participants n=93 Participants	48 participants n=4 Participants	97 participants n=27 Participants
Lupus Nephritis (LN) history Years since diagnosis of systemic lupus erythematosus (SLE)	6.6 years STANDARD_DEVIATION 6.41 • n=93 Participants	6.9 years STANDARD_DEVIATION 6.07 • n=4 Participants	6.7 years STANDARD_DEVIATION 6.23 • n=27 Participants
Lupus Nephritis (LN) history Years since diagnosis of LN	4.6 years STANDARD_DEVIATION 5.07 • n=93 Participants	4.7 years STANDARD_DEVIATION 4.89 • n=4 Participants	4.6 years STANDARD_DEVIATION 4.97 • n=27 Participants
Lupus Nephritis (LN) history Years since first Proteinuria	4.8 years STANDARD_DEVIATION 5.2 • n=93 Participants	4.6 years STANDARD_DEVIATION 4.51 • n=4 Participants	4.7 years STANDARD_DEVIATION 4.86 • n=27 Participants
Baseline Urine Protein Creatinine Ratio (UPCR)	4.14 mg/mg STANDARD_DEVIATION 2.711 • n=93 Participants	3.87 mg/mg STANDARD_DEVIATION 2.363 • n=4 Participants	4.00 mg/mg STANDARD_DEVIATION 2.537 • n=27 Participants
Baseline estimated glomerular filtration rate (eGFR)	92.1 mL/min/1.73 m2 STANDARD_DEVIATION 30.06 • n=93 Participants	90.4 mL/min/1.73 m2 STANDARD_DEVIATION 28.97 • n=4 Participants	91.2 mL/min/1.73 m2 STANDARD_DEVIATION 29.51 • n=27 Participants

PRIMARY outcome

Timeframe: 52 Weeks

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Participants With Adjudicated Renal Response at Week 52 Number of renal responders	73 Participants	40 Participants
Number of Participants With Adjudicated Renal Response at Week 52 Number of renal non-responders	106 Participants	138 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Intent to Treat

Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less Subjects with UPCR ≤ 0.5	116 Participants	78 Participants
Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less Subjects without UPCR ≤ 0.5	63 Participants	100 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: Intent to Treat

Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)	169 days Interval 141.0 to 214.0	372 days Interval 295.0 to Upper limit not calculated due to censored data

SECONDARY outcome

Timeframe: Week 24

Population: intent to Treat

Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on 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%, and 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 16 through 24, just prior to the renal response 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 AND confirmed \>20% drop from BL) \& have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Participants With Renal Response at Week 24 Number of renal responders	58 Participants	35 Participants
Number of Participants With Renal Response at Week 24 Number of renal non-responders	121 Participants	143 Participants

SECONDARY outcome

Timeframe: Weeks 24 and 52

Population: Intent to Treat

Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Subjects With Partial Renal Response at Weeks 24 & 52 Week 24	126 Participants	89 Participants
Number of Subjects With Partial Renal Response at Weeks 24 & 52 Week 52	125 Participants	92 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent to Treat population achieving UPCR \<0.5 mg/mg

Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg) Subjects achieving UPCR ≤ 0.5 mg/mg	116 Participants	78 Participants
Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg) number with 2nd occurrence of UPCR > 0.5 mg/mg	53 Participants	37 Participants
Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg) number without 2nd occurrence of UPCR > 0.5 mg/mg	63 Participants	41 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent to Treat

Duration in days until second occurrence of UPCR \>0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg

Outcome measures

Outcome measures
Measure	Voclosporin n=116 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=78 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Duration of Renal Response (Number of Days)	216 days Interval 127.0 to Upper limit not calculated due to censored data	198 days Interval 103.0 to Upper limit not calculated due to censored data

SECONDARY outcome

Timeframe: 52 Weeks

Population: Intent-to-Treat

Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio Subjects with 50% UPCR reduction	173 Participants	135 Participants
Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio Subjects without 50% UPCR reduction	6 Participants	43 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intent to Treat

Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Time to 50% Reduction in UPCR (Number of Days)	29 days Interval 29.0 to 32.0	63 days Interval 57.0 to 87.0

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.

Population: Intent to Treat

Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Change From Baseline in eGFR Baseline	78.3 ml/min/1.73 square metres Standard Deviation 15.83	77.4 ml/min/1.73 square metres Standard Deviation 16.98
Change From Baseline in eGFR Week 2 change from baseline	-1.5 ml/min/1.73 square metres Standard Deviation 9.44	3.3 ml/min/1.73 square metres Standard Deviation 10.12
Change From Baseline in eGFR Week 4 change from baseline	-0.4 ml/min/1.73 square metres Standard Deviation 10.39	3.2 ml/min/1.73 square metres Standard Deviation 9.86
Change From Baseline in eGFR Week 8 change from baseline	-0.9 ml/min/1.73 square metres Standard Deviation 13.1	3.8 ml/min/1.73 square metres Standard Deviation 11.27
Change From Baseline in eGFR Week 12 change from baseline	-0.3 ml/min/1.73 square metres Standard Deviation 11.74	3.3 ml/min/1.73 square metres Standard Deviation 12.85
Change From Baseline in eGFR Week 16 change from baseline	-0.1 ml/min/1.73 square metres Standard Deviation 12.27	2.8 ml/min/1.73 square metres Standard Deviation 13.25
Change From Baseline in eGFR Week 20 change from baseline	-0.7 ml/min/1.73 square metres Standard Deviation 12.09	3.2 ml/min/1.73 square metres Standard Deviation 13.04
Change From Baseline in eGFR Week 24 change from baseline	-0.3 ml/min/1.73 square metres Standard Deviation 13.8	2.8 ml/min/1.73 square metres Standard Deviation 13.84
Change From Baseline in eGFR Week 30 change from baseline	-0.8 ml/min/1.73 square metres Standard Deviation 14.2	1.8 ml/min/1.73 square metres Standard Deviation 14.4
Change From Baseline in eGFR Week 36 change from baseline	-1.9 ml/min/1.73 square metres Standard Deviation 14.89	1.5 ml/min/1.73 square metres Standard Deviation 14.84
Change From Baseline in eGFR Week 42 change from baseline	-2.8 ml/min/1.73 square metres Standard Deviation 16.7	1.5 ml/min/1.73 square metres Standard Deviation 15.53
Change From Baseline in eGFR Week 48 change from baseline	-3.6 ml/min/1.73 square metres Standard Deviation 17.2	1.1 ml/min/1.73 square metres Standard Deviation 15.71
Change From Baseline in eGFR Week 52 change from baseline	-1.5 ml/min/1.73 square metres Standard Deviation 16.16	1.5 ml/min/1.73 square metres Standard Deviation 15

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.

Population: Intent to Treat

Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Change From Baseline in UPCR Baseline	4.14 mg/mg Standard Deviation 2.711	3.87 mg/mg Standard Deviation 2.363
Change From Baseline in UPCR Week 2 change from baseline	-1.46 mg/mg Standard Deviation 1.991	-0.7 mg/mg Standard Deviation 2.312
Change From Baseline in UPCR Week 4 change from baseline	-1.98 mg/mg Standard Deviation 2.29	-1.07 mg/mg Standard Deviation 2.155
Change From Baseline in UPCR Week 8 change from baseline	-2.23 mg/mg Standard Deviation 2.213	-1.43 mg/mg Standard Deviation 2.448
Change From Baseline in UPCR Week 12 change from baseline	-2.56 mg/mg Standard Deviation 2.293	-1.48 mg/mg Standard Deviation 2.688
Change From Baseline in UPCR Week 16 change from baseline	-2.75 mg/mg Standard Deviation 2.462	-1.58 mg/mg Standard Deviation 2.81
Change From Baseline in UPCR Week 20 change from baseline	-2.74 mg/mg Standard Deviation 2.968	-1.54 mg/mg Standard Deviation 2.82
Change From Baseline in UPCR Week 24 change from baseline	-2.74 mg/mg Standard Deviation 2.567	-1.59 mg/mg Standard Deviation 2.899
Change From Baseline in UPCR Week 30 change from baseline	-2.66 mg/mg Standard Deviation 3.336	-1.7 mg/mg Standard Deviation 3.112
Change From Baseline in UPCR Week 36 change from baseline	-2.74 mg/mg Standard Deviation 2.871	-1.63 mg/mg Standard Deviation 3.188
Change From Baseline in UPCR Week 42 change from baseline	-2.91 mg/mg Standard Deviation 2.522	-1.78 mg/mg Standard Deviation 3.39
Change From Baseline in UPCR Week 48 change from baseline	-2.71 mg/mg Standard Deviation 2.807	-1.8 mg/mg Standard Deviation 3.004
Change From Baseline in UPCR Week 52 change from baseline	-2.65 mg/mg Standard Deviation 2.872	-1.88 mg/mg Standard Deviation 3.05

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: Intent to Treat

Programmed Renal Response whilst on low dose steroids (\<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Number of Subjects With Renal Response With Low Dose Steroids Renal Response at Week 24	32 Participants	16 Participants
Number of Subjects With Renal Response With Low Dose Steroids Renal Response at Week 52	64 Participants	36 Participants

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: Intent to Treat

Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52. The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI) Change from baseline at Week 24	-4.5 scores on a scale Interval -5.4 to -3.7	-4.1 scores on a scale Interval -5.0 to -3.2
Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI) Change from baseline at Week 52	-6 scores on a scale Interval -6.7 to -5.2	-5.5 scores on a scale Interval -6.3 to -4.7

SECONDARY outcome

Timeframe: Week 24 and Week 52

Population: Intent to Treat

Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment. The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health. LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.

Outcome measures

Outcome measures
Measure	Voclosporin n=179 Participants oral, 23.7 mg BID Voclosporin: calcineurin inhibitor	Placebo Oral Capsule n=178 Participants Voclosporin placebo, oral, 3 capsules BID Placebo Oral Capsule: matching placebo capsule
Change From Baseline in Patient Reported Outcomes SF-36 change from baseline at Week 24	6.64 score on a scale Interval 4.34 to 8.93	7.11 score on a scale Interval 4.8 to 9.42
Change From Baseline in Patient Reported Outcomes SF-36 change from baseline at Week 52	10.44 score on a scale Interval 8.04 to 12.83	10.81 score on a scale Interval 8.37 to 13.25
Change From Baseline in Patient Reported Outcomes LupusPRO HRQOL change from baseline at Week 24	7.7 score on a scale Interval 5.4 to 10.13	6.06 score on a scale Interval 3.68 to 8.45
Change From Baseline in Patient Reported Outcomes LupusPRO HRQOL change from baseline at Week 52	9.24 score on a scale Interval 6.78 to 11.7	9.84 score on a scale Interval 7.33 to 12.35
Change From Baseline in Patient Reported Outcomes LupusPRO non-HRQOL change from baseline at Week 24	1.06 score on a scale Interval -1.32 to 3.44	2.94 score on a scale Interval 0.54 to 5.35
Change From Baseline in Patient Reported Outcomes LupusPRO non-HRQOL change from baseline at Week 52	4.08 score on a scale Interval 1.6 to 6.56	3.74 score on a scale Interval 1.22 to 6.26

Adverse Events

Voclosporin

Serious events: 37 serious events

Other events: 161 other events

Deaths: 1 deaths

Placebo Oral Capsule

Serious events: 38 serious events

Other events: 156 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Rashieda Gluck

Aurinia Pharmaceuticals

Phone: 1 (250) 744-2487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Voclosporin n=178 participants at risk Voclosporin 23.7 mg BID + Mycophenolate Mofetil + corticosteroid	Placebo Oral Capsule n=178 participants at risk Placebo 23.7 mg BID + Mycophenolate Mofetil + corticosteroid
Infections and infestations Upper respiratory tract infection	17.4% 31/178 • Number of events 44 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	14.6% 26/178 • Number of events 33 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Infections and infestations Viral upper respiratory tract infection	11.2% 20/178 • Number of events 24 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	10.1% 18/178 • Number of events 20 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Infections and infestations Urinary tract infection	9.6% 17/178 • Number of events 25 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	7.3% 13/178 • Number of events 14 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Infections and infestations Herpes zoster	7.3% 13/178 • Number of events 13 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.1% 9/178 • Number of events 9 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Infections and infestations Influenza	6.7% 12/178 • Number of events 15 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.6% 10/178 • Number of events 12 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Infections and infestations Gastroenteritis	3.9% 7/178 • Number of events 8 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.6% 10/178 • Number of events 10 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Infections and infestations Pharyngitis	1.7% 3/178 • Number of events 3 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.1% 9/178 • Number of events 11 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Gastrointestinal disorders Diarrhoea	19.1% 34/178 • Number of events 43 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	11.8% 21/178 • Number of events 23 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Gastrointestinal disorders Abdominal pain upper	7.3% 13/178 • Number of events 13 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	0.56% 1/178 • Number of events 2 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Gastrointestinal disorders Abdominal pain	5.6% 10/178 • Number of events 11 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	1.1% 2/178 • Number of events 3 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Gastrointestinal disorders Nausea	5.6% 10/178 • Number of events 10 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	9.6% 17/178 • Number of events 18 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Gastrointestinal disorders Dyspepsia	5.6% 10/178 • Number of events 10 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	1.7% 3/178 • Number of events 3 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Gastrointestinal disorders Vomiting	2.8% 5/178 • Number of events 6 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	6.7% 12/178 • Number of events 17 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Investigations Glomerular filtration rate decreased	24.2% 43/178 • Number of events 61 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	8.4% 15/178 • Number of events 19 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Nervous system disorders Headache	16.3% 29/178 • Number of events 34 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	6.2% 11/178 • Number of events 16 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Skin and subcutaneous tissue disorders Alopecia	5.6% 10/178 • Number of events 10 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	2.8% 5/178 • Number of events 5 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 8/178 • Number of events 9 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	9.6% 17/178 • Number of events 20 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Vascular disorders Hypertension	19.7% 35/178 • Number of events 38 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	7.9% 14/178 • Number of events 15 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
General disorders Oedema peripheral	6.2% 11/178 • Number of events 11 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	6.2% 11/178 • Number of events 11 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Blood and lymphatic system disorders Anaemia	10.1% 18/178 • Number of events 19 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.6% 10/178 • Number of events 11 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Blood and lymphatic system disorders Leukopenia	3.9% 7/178 • Number of events 8 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.6% 10/178 • Number of events 12 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Respiratory, thoracic and mediastinal disorders Cough	7.3% 13/178 • Number of events 13 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	1.7% 3/178 • Number of events 3 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Renal and urinary disorders Renal impairment	6.2% 11/178 • Number of events 14 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	2.8% 5/178 • Number of events 6 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Renal and urinary disorders Lupus nephritis	0.56% 1/178 • Number of events 1 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	4.5% 8/178 • Number of events 8 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Renal and urinary disorders Proteinuria	0.00% 0/178 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	4.5% 8/178 • Number of events 8 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose
Metabolism and nutrition disorders Hypokalaemia	1.7% 3/178 • Number of events 3 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose	5.1% 9/178 • Number of events 9 • Reporting period is from first dose up to 30 days following last dose (Week 52). Treatment emergent Deaths and serious adverse events (SAEs). Reporting period is from first dose up to 30 days following last dose