Clinical Trial Finder

Voclosporin in Adolescents With Lupus Nephritis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 12 Years - 17 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05288855
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Aurinia Pharmaceuticals Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adolescent Lupus Nephritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Voclosporin treatment group 1

2 capsules (15.8 mg) BID of voclosporin

Placebo Comparator: Placebo treatment group

2 capsules BID of placebo

Experimental: Voclosporin treatment group 3

3 capsules (23.7 mg) BID of voclosporin

Experimental: Voclosporin treatment group 4

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

Interventions

Drug: - Voclosporin

calcineurin inhibitor

Drug: - Placebo Oral Capsule

matching placebo capsule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UNC-Chapel Hill, Chapel Hill, North Carolina

Status

Recruiting

Address

UNC-Chapel Hill

Chapel Hill, North Carolina, 27514

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