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Immunosuppressant

Voclosporin for Lupus Nephritis (VOCAL Trial)

Phase 3
Recruiting
Research Sponsored by Aurinia Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria
Subjects with kidney biopsy confirmed active lupus nephritis
Must not have
Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid
Malignant neoplasm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights
Pivotal Trial

Summary

This trial is testing if a new drug, voclosporin, is better than placebo at improving kidney function in teens with active lupus nephritis.

Who is the study for?
Adolescents previously diagnosed with systemic lupus erythematosus and confirmed active lupus nephritis can join. They must have a kidney function above a certain level (eGFR >60) and not be immunocompromised or have significant drug/alcohol abuse, cancer, severe infections like HIV or hepatitis, TB without prophylaxis, or require dialysis.
What is being tested?
The trial is testing the effectiveness of voclosporin against a placebo in treating lupus nephritis over 24 weeks. Participants will either receive voclosporin capsules or placebo to see if there's an improvement in their kidney condition.
What are the potential side effects?
While specific side effects for this trial are not listed here, voclosporin may generally cause immune system suppression leading to increased infection risk, potential kidney problems, high blood pressure, tremors, and possible interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lupus according to the 2019 criteria.
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My kidney biopsy confirmed I have active lupus nephritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active TB nor a history of TB without taking TB prevention medication.
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I have been diagnosed with cancer.
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I have had a disease affecting my lymph nodes or received radiation targeting all my lymph nodes.
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I have a weakened immune system from birth or due to a condition.
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I have not had severe viral infections or HIV, hepatitis B or C in the last 3 months.
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I am on or expected to need kidney dialysis during the study.
Select...
My kidney function is reduced, with an eGFR below 60.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects with renal response
Secondary study objectives
Number of treatment-emergent adverse events (TEAEs) will be summarized by treatment group
Proportion of subjects with partial renal response
Time to 50% Reduction in UPCR
+1 more

Side effects data

From 2019 Phase 3 trial • 358 Patients • NCT03021499
24%
Glomerular filtration rate decreased
20%
Hypertension
19%
Diarrhoea
17%
Upper respiratory tract infection
16%
Headache
11%
Viral upper respiratory tract infection
10%
Urinary tract infection
10%
Anaemia
7%
Cough
7%
Herpes zoster
7%
Influenza
7%
Abdominal pain upper
6%
Renal impairment
6%
Oedema peripheral
6%
Abdominal pain
6%
Nausea
6%
Dyspepsia
6%
Alopecia
4%
Leukopenia
4%
Arthralgia
4%
Gastroenteritis
4%
Pneumonia
3%
Vomiting
2%
Acute kidney injury
2%
Pharyngitis
2%
Hypokalaemia
2%
Systemic lupus erythematosus
1%
Gastritis
1%
Pulmonary tuberculosis
1%
Generalised oedema
1%
Cervix carcinoma stage 0
1%
Lung abscess
1%
Pneumonia cytomegaloviral
1%
Lupus nephritis
1%
Cerebral infarction
1%
Lupus encephalitis
1%
Migraine
1%
Neuropsychiatric lupus
1%
Neutropenia
1%
Cardiac failure congestive
1%
Blood lactate dehydrogenase increased
1%
Pleural effusion
1%
Intentional overdose
1%
Abortion induced
1%
Cardiac failure
1%
Cardiac failure acute
1%
Developmental hip dysplasia
1%
Renal failure
1%
Pyelonephritis acute
1%
Acute sinusitis
1%
Bacterial diarrhoea
1%
Cystitis
1%
Hypertensive crisis
1%
Acute coronary syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Oral Capsule
Voclosporin

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Voclosporin treatment group 4Experimental Treatment1 Intervention
Maximum dose of 4 capsules (31.6 mg) BID of voclosporin.
Group II: Voclosporin treatment group 3Experimental Treatment1 Intervention
3 capsules (23.7 mg) BID of voclosporin
Group III: Voclosporin treatment group 1Experimental Treatment1 Intervention
2 capsules (15.8 mg) BID of voclosporin
Group IV: Placebo treatment groupPlacebo Group1 Intervention
2 capsules BID of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Voclosporin
2022
Completed Phase 3
~1000

Find a Location

Who is running the clinical trial?

Labcorp Corporation of America Holdings, IncIndustry Sponsor
19 Previous Clinical Trials
4,561 Total Patients Enrolled
1 Trials studying Lupus Nephritis
40 Patients Enrolled for Lupus Nephritis
Aurinia Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
3,622 Total Patients Enrolled
6 Trials studying Lupus Nephritis
1,189 Patients Enrolled for Lupus Nephritis
Labcorp Drug Development, Inc.Industry Sponsor
10 Previous Clinical Trials
497 Total Patients Enrolled

Media Library

Voclosporin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288855 — Phase 3
~0 spots leftby Dec 2024
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