A study to look at the effect and how safe the drug, Voclosporin, is in adolescents with a type of kidney disease called Lupus Nephritis

Phase 1

Conditions: upus Nephritis
MedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2020-005807-37-IT

Lead Sponsor: Aurinia Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Male or female subjects 12 to <18 years of age at the time of screening
2. Previous diagnosis of SLE according to the 2019 EULAR/ACR classification criteria.
3. Subjects with kidney biopsy result, with evidence of active nephritis

Refer to protocol for full list of inclusion criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Estimated glomerular filtration rate of <60 mL/min/1.73 m2 at screening confirmed before randomization
2. Use of immunosuppression biologic agents within 12 weeks prior to randomization
3. Use of cyclophosphamide, cholestyramine, calcineurin inhibitors, live attenuated vaccines and initiation or dose changes in ARBs and ACEi within 4 weeks prior to
randomisation
4. Use of Strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization
5. Currently requiring renal dialysis or expected to require dialysis during the study period
6. A previous kidney transplant or planned transplant within study treatment period.
7. 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.
8. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions
Refer to protocol for full list of exclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active LN.;Secondary Objective: •To assess the safety and tolerability of voclosporin over 24 weeks in adolescents with active LN.<br>•To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of voclosporin in adolescents with LN.<br>•To assess the palatability and acceptability of voclosporin softgel capsules.;Primary end point(s): Renal response at Week 24 will be adjudicated by the Clinical Endpoints Committee (CEC) based on the following parameters:<br>• UPCR of <=0.5 mg/mg, and<br>• eGFR >=60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and<br>• Received no rescue medication for LN, and<br>• Did not receive >10 mg/day prednisone for >=3 consecutive days or for >=7 days in total between Week 16 and Week 24.;Timepoint(s) of evaluation of this end point: At week 24

Secondary Outcome Measures

Name	Time	Method

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