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

• Register: EUCTR
• Last refreshed on: 29 November 2021
• Main ID: EUCTR2016-004046-28-HR
• Date of registration: 13/04/2018
• Prospective Registration: No
• Primary sponsor: Aurinia Pharmaceuticals, Inc.
• Public title: A clinical study to assess the long-term safety and efficacy of Orelvo (voclosporin) compared with placebo in subjects with active lupus nephritis (LN)
• Scientific title: 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
• Date of first enrolment: 04/04/2018
• Target sample size: 324
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004046-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Project Management
• Affiliation: Worldwide Clinical Trials Ltd

• Name: Project Management
• Affiliation: Worldwide Clinical Trials Ltd

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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: VOCLOSPORIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.9-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

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).

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.

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

Secondary Outcome(s)

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

Secondary ID(s)

2016-004046-28-ES

AUR-VCS-2016-02

Source(s) of Monetary Support

Aurinia Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date: 20/02/2018
Contact: