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

A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis - VOCAL

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005807-37-ES

Enrollment

Registered

2022-01-18

Start date

2022-04-08

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Lupus Nephritis MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Voclosporin Pharmaceutical Form: Capsule, soft INN or Proposed INN: Voclosporin CAS Number: 515814-01-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects 12 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. •To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of voclosporin in adolescents with LN. •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: • UPCR of =0.5 mg/mg, and • eGFR =60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and • Received no rescue medication for LN, and • 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	—

Measure

Time frame

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. •To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of voclosporin in adolescents with LN. •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: • UPCR of =0.5 mg/mg, and • eGFR =60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and • Received no rescue medication for LN, and • 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

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Secondary

Measure	Time frame
Secondary end point(s): • Time to UPCR of =0.5 mg/mg. • UPCR of =0.7 mg/mg at Week 24. • Time to UPCR of =0.7 mg/mg. • Partial renal response as defined by =50% reduction from baseline in UPCR at Week 24. • Time to 50% reduction in UPCR from baseline. • Proportion of subjects with renal flare, defined as: o At least a doubling in UPCR to =1.0 mg/mg for Class III, IV-S, or Class IVG alone or in combination with Class V or =2.0 mg/mg for Class V only OR o At least a doubling in serum creatinine to =120 µmol/L (~1.37 mg/dL). • Proportion of subjects with extra-renal flare, defined as an increase in 4-6 points on the extra-renal domains in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24. • Change from baseline in UPCR at each time point up to and including Week 24. • Change from baseline in eGFR, urine protein and serum creatinine at each time point up to and including Week 24. • Proportion of subjects with a decrease in eGFR >30% at each time point up to and including Week 24. • Change from screening in immunology parameters (complement 3 (C3), C4, and anti-double-stranded DNA) at each time point up to and including Week 24. • Change from baseline in the SELENA-SLEDAI score at Week 24. • Proportion of subjects with prednisone equivalent <7.5 mg/day at Week 24. • Adverse events (AE) profile, electrocardiograms (ECGs) and routine biochemical and hematological assessment over time up to and including Week 24 plus Safety Follow-Up period. • PK parameters and calcineurin inhibition of voclosporin at steady state (Week 8) • Palatability and acceptability of voclosporin softgel capsules;Timepoint(s) of evaluation of this end point: Refer to schedule of events	—

Measure

Time frame

Secondary end point(s): • Time to UPCR of =0.5 mg/mg. • UPCR of =0.7 mg/mg at Week 24. • Time to UPCR of =0.7 mg/mg. • Partial renal response as defined by =50% reduction from baseline in UPCR at Week 24. • Time to 50% reduction in UPCR from baseline. • Proportion of subjects with renal flare, defined as: o At least a doubling in UPCR to =1.0 mg/mg for Class III, IV-S, or Class IVG alone or in combination with Class V or =2.0 mg/mg for Class V only OR o At least a doubling in serum creatinine to =120 µmol/L (~1.37 mg/dL). • Proportion of subjects with extra-renal flare, defined as an increase in 4-6 points on the extra-renal domains in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24. • Change from baseline in UPCR at each time point up to and including Week 24. • Change from baseline in eGFR, urine protein and serum creatinine at each time point up to and including Week 24. • Proportion of subjects with a decrease in eGFR >30% at each time point up to and including Week 24. • Change from screening in immunology parameters (complement 3 (C3), C4, and anti-double-stranded DNA) at each time point up to and including Week 24. • Change from baseline in the SELENA-SLEDAI score at Week 24. • Proportion of subjects with prednisone equivalent <7.5 mg/day at Week 24. • Adverse events (AE) profile, electrocardiograms (ECGs) and routine biochemical and hematological assessment over time up to and including Week 24 plus Safety Follow-Up period. • PK parameters and calcineurin inhibition of voclosporin at steady state (Week 8) • Palatability and acceptability of voclosporin softgel capsules;Timepoint(s) of evaluation of this end point: Refer to schedule of events

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Countries

Colombia, France, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Peru, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactClinical Trial Information

Aurinia Pharmaceuticals Inc.

clinicaltrials@auriniapharma.com+1-250-508-3598

Outcome results

None listed

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