A clinical study to assess the long-term safety and efficacy of Orelvo (voclosporin) compared with placebo in subjects with active lupus nephritis (LN)

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis - AURORA (AURinia Orelvo Renal Assessments) 2: Aurinia Renal Response in Lupus with Orelvo

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004046-28-ES

Enrollment

324

Registered

2018-01-25

Start date

2018-05-23

Completion date

Unknown

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis MedDRA version: 20.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Orelvo Product Code: Voclosporin Pharmaceutical Form: Capsule, soft INN or Proposed INN: Voclosporin CAS Number: 515814-01-4 Current Sponsor code: ISA247 Other descriptive name: VOCLOSPO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Written informed consent before any study-specific procedures are performed. 2.Male or female 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. 3.In the opinion of the Investigator, subject requires continued immunosuppressive therapy. 4.Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study (see Protocol Section 5.4, Adequate/Effective Contraception). 5.Subject is willing to continue taking oral MMF for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 310 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: 1.Subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2.Currently taking or known need for any of the medications or food items listed in Protocol Section 7.8, Prohibited Therapy and Concomitant Treatment during the study. 3.Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. 4.A planned kidney transplant within study treatment period. 5.Subjects with any medical condition which, in the Investigator’s judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes. 6.Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7.Vaccines using live organisms, virus or bacterial, while taking the study treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).;Secondary Objective: To assess the long-term efficacy of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN;Primary end point(s): Adverse events (AE) profile and routine biochemical and hematological assessments.;Timepoint(s) of evaluation of this end point: At the end of the study, but as part of that analysis, it will be looked at each study visit.	—

Measure

Time frame

Main Objective: To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).;Secondary Objective: To assess the long-term efficacy of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN;Primary end point(s): Adverse events (AE) profile and routine biochemical and hematological assessments.;Timepoint(s) of evaluation of this end point: At the end of the study, but as part of that analysis, it will be looked at each study visit.

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Secondary

Measure	Time frame
Secondary end point(s): - Proportion of subjects in renal response defined as: · UPCR of =0.5 mg/mg · estimated glomerular filtration rate (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 the 8 weeks prior to the renal response assessment. - Subjects who withdraw from the study prior to the response assessment will be defined as non-responders. - Proportion of subjects in partial renal response defined as a 50% reduction from baseline in UPCR. - Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). - Extra-renal flare as adjudicated by the CEC. - SELENA-SLEDAI scores by visit. - Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline. - Change in immunology parameters (complement 3 (C3), complement 4 (C4), and anti double-stranded deoxyribonucleic acid (DNA)) from AURORA 1 baseline. - Change in health-related quality of life (HRQoL) (SF-36) from AURORA 1 baseline. - Healthcare Resource Utilization (HRU).;Timepoint(s) of evaluation of this end point: • Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline at each visit. • Change in immunology parameters (C3, C4, and anti-dsDNA) from AURORA 1 baseline at each visit. • Change in HRQoL (SF-36) from AURORA 1 baseline at Months 12, 18, 24, 30, and 36. • Change in SELENA-SLEDAI scores by visit at Months 12, 18, 24, and 36. • Healthcare Resource Utilization at Months 12, 15, 18, 21, 24, 27, 30, 33, and 36. Key aspects will be summarized by visit and changes over time will be explored	—

Measure

Time frame

Secondary end point(s): - Proportion of subjects in renal response defined as: · UPCR of =0.5 mg/mg · estimated glomerular filtration rate (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 the 8 weeks prior to the renal response assessment. - Subjects who withdraw from the study prior to the response assessment will be defined as non-responders. - Proportion of subjects in partial renal response defined as a 50% reduction from baseline in UPCR. - Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). - Extra-renal flare as adjudicated by the CEC. - SELENA-SLEDAI scores by visit. - Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline. - Change in immunology parameters (complement 3 (C3), complement 4 (C4), and anti double-stranded deoxyribonucleic acid (DNA)) from AURORA 1 baseline. - Change in health-related quality of life (HRQoL) (SF-36) from AURORA 1 baseline. - Healthcare Resource Utilization (HRU).;Timepoint(s) of evaluation of this end point: • Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline at each visit. • Change in immunology parameters (C3, C4, and anti-dsDNA) from AURORA 1 baseline at each visit. • Change in HRQoL (SF-36) from AURORA 1 baseline at Months 12, 18, 24, 30, and 36. • Change in SELENA-SLEDAI scores by visit at Months 12, 18, 24, and 36. • Healthcare Resource Utilization at Months 12, 15, 18, 21, 24, 27, 30, 33, and 36. Key aspects will be summarized by visit and changes over time will be explored

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Countries

Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Dominican Republic, Guatemala, Japan, Korea, Republic of, Macedonia, the former Yugoslav Republic of, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Russian Federation, Serbia, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam

Contacts

Public ContactProject Management

Worldwide Clinical Trials Ltd

+44(0)207 1216161

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026