Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2028-06-30

Brief Summary

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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 adolescent and pediatric subjects with active lupus nephritis (LN).

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Detailed Description

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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: Period 1 is double-blind, placebo controlled receiving 15.8 mg twice daily, Period 2 is open-label receiving 23.7 mg twice daily, Period 3 is open-label receiving 15.8 mg twice daily.

Conditions

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Adolescent Lupus Nephritis Pediatric Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind (participant, care provider, investigator and outcome assessor) for period 1 and Open-label for period 2 and period 3

Study Groups

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Voclosporin treatment group 1

2 capsules (15.8 mg) BID of voclosporin

Group Type EXPERIMENTAL

Voclosporin

Intervention Type DRUG

calcineurin inhibitor

Placebo treatment group 2

2 capsules BID of placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

matching placebo capsule

Voclosporin treatment group 3

3 capsules (23.7 mg) BID of voclosporin

Group Type EXPERIMENTAL

Voclosporin

Intervention Type DRUG

calcineurin inhibitor

Voclosporin treatment group 4

Maximum dose of 2 capsules (15.8 mg) BID of voclosporin.

Group Type EXPERIMENTAL

Voclosporin

Intervention Type DRUG

calcineurin inhibitor

Interventions

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Voclosporin

calcineurin inhibitor

Intervention Type DRUG

Placebo Oral Capsule

matching placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No