Voclosporin in Adolescents With Lupus Nephritis (VOCAL)

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

The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active lupus nephritis (LN).

Study Overview

• Status: Recruiting
• Conditions: Adolescent Lupus Nephritis
• Intervention / Treatment: Drug: Voclosporin; Drug: Placebo Oral Capsule

Detailed Description

This is a 24 week, dose escalation study of voclosporin in addition to standard of care with mycophenolate mofetil (MMF) and steroids, consisting of 3 treatment periods, in which period 1 is double-blind, placebo controlled, and period 2 and period 3 are open-label, with increasing doses of voclosporin in a pediatric population.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Antonia Coeshall; Phone Number: +44-7968-836321; Email: acoeshall@auriniapharma.com

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • UNC-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
• Subjects with kidney biopsy confirmed active lupus nephritis.

Exclusion Criteria:

• Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.

• Current or medical history of:

  • Congenital or acquired immunodeficiency.
  • Clinically significant drug or alcohol abuse prior to screening.
  • Malignant neoplasm.
  • Lymphoproliferative disease or previous total lymphoid irradiation.
  • Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
  • Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
• Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.

• Currently taking or known need for any of the following medications:

  • Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Voclosporin treatment group 1; 2 capsules (15.8 mg) BID of voclosporin	Drug: Voclosporin; calcineurin inhibitor
Placebo Comparator: Placebo treatment group; 2 capsules BID of placebo	Drug: Placebo Oral Capsule; matching placebo capsule
Experimental: Voclosporin treatment group 3; 3 capsules (23.7 mg) BID of voclosporin	Drug: Voclosporin; calcineurin inhibitor
Experimental: Voclosporin treatment group 4; Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.	Drug: Voclosporin; calcineurin inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with renal response	Renal response defined as UPCR ≤0.5 mg/mg, eGFR ≥60 mL/min/1.73 m2 or no decrease from baseline of >20%, no rescue medication and no steroid use >10 mg/day for ≥3 consecutive days or for ≥7 days in total between week 16 to 24	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to UPCR of ≤0.5 mg/mg.	Time in days to reduction in UPCR to ≤ 0.5 mg/mg	Baseline to Week 24
Proportion of subjects with partial renal response	defined as ≥50% reduction from baseline in UPCR	Week 24
Time to 50% Reduction in UPCR	Time in days to reduction from baseline UPCR of at least 50% Organ Class, and preferred term.	Baseline to Week 24
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group	Treatment-emergent adverse events will be summarized by treatment group, System Organ Class, and preferred term	Baseline to Week 24

Collaborators and Investigators

• Sponsor: Aurinia Pharmaceuticals Inc.
• Collaborators: Labcorp Drug Development Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: adolescents; voclosporin; Lupus nephritis; calcineurin inhibitors
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis
• Other Study ID Numbers: AUR-VCS-2020-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No