search
Back to results

Voclosporin in Adolescents With Lupus Nephritis (VOCAL)

Primary Purpose

Adolescent Lupus Nephritis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Voclosporin
Placebo Oral Capsule
Sponsored by
Aurinia Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Lupus Nephritis focused on measuring Lupus nephritis, calcineurin inhibitors, voclosporin, adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNC-Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Voclosporin treatment group 1

Placebo treatment group

Voclosporin treatment group 3

Voclosporin treatment group 4

Arm Description

2 capsules (15.8 mg) BID of voclosporin

2 capsules BID of placebo

3 capsules (23.7 mg) BID of voclosporin

Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to UPCR of ≤0.5 mg/mg.
Time in days to reduction in UPCR to ≤ 0.5 mg/mg
Proportion of subjects with partial renal response
defined as ≥50% reduction from baseline in UPCR
Time to 50% Reduction in UPCR
Time in days to reduction from baseline UPCR of at least 50% Organ Class, and preferred term.
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

Full Information

First Posted
March 11, 2022
Last Updated
October 20, 2023
Sponsor
Aurinia Pharmaceuticals Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05288855
Brief Title
Voclosporin in Adolescents With Lupus Nephritis
Acronym
VOCAL
Official Title
A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents With Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurinia Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Lupus Nephritis
Keywords
Lupus nephritis, calcineurin inhibitors, voclosporin, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind (participant, care provider, investigator and outcome assessor) for period 1 and Open-label for period 2 and period 3
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voclosporin treatment group 1
Arm Type
Experimental
Arm Description
2 capsules (15.8 mg) BID of voclosporin
Arm Title
Placebo treatment group
Arm Type
Placebo Comparator
Arm Description
2 capsules BID of placebo
Arm Title
Voclosporin treatment group 3
Arm Type
Experimental
Arm Description
3 capsules (23.7 mg) BID of voclosporin
Arm Title
Voclosporin treatment group 4
Arm Type
Experimental
Arm Description
Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.
Intervention Type
Drug
Intervention Name(s)
Voclosporin
Intervention Description
calcineurin inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Intervention Description
matching placebo capsule
Primary Outcome Measure Information:
Title
Proportion of subjects with renal response
Description
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
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Time to UPCR of ≤0.5 mg/mg.
Description
Time in days to reduction in UPCR to ≤ 0.5 mg/mg
Time Frame
Baseline to Week 24
Title
Proportion of subjects with partial renal response
Description
defined as ≥50% reduction from baseline in UPCR
Time Frame
Week 24
Title
Time to 50% Reduction in UPCR
Description
Time in days to reduction from baseline UPCR of at least 50% Organ Class, and preferred term.
Time Frame
Baseline to Week 24
Title
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
Description
Treatment-emergent adverse events will be summarized by treatment group, System Organ Class, and preferred term
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Coeshall
Phone
+44-7968-836321
Email
acoeshall@auriniapharma.com
Facility Information:
Facility Name
UNC-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Voclosporin in Adolescents With Lupus Nephritis

We'll reach out to this number within 24 hrs