Voclosporin for Lupus Nephritis

(VOCAL Trial)

Recruiting at 6 trial locations

Overseen By Aurinia Clinical Trials Information

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Aurinia Pharmaceuticals Inc.

Must not be taking: Biologics, Cyclophosphamide, CNIs, others

Disqualifiers: Immunodeficiency, Neoplasm, HIV, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of voclosporin, an immunosuppressant drug, for treating lupus nephritis—a kidney condition caused by lupus—in young patients. Participants will receive either varying doses of voclosporin or a placebo (a pill with no active drug) to compare results. Ideal candidates are those already diagnosed with lupus and have had a kidney biopsy showing active lupus nephritis. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take certain immune system drugs, some blood pressure medications, or certain other drugs close to the start of the trial. It's best to discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that voclosporin is generally safe for people with lupus nephritis. In earlier studies, most patients tolerated voclosporin well over long-term use. One study found that 86.1% of patients completed their treatment without unexpected safety issues. Serious side effects occurred in 21% of both the voclosporin and placebo groups, indicating a similar risk to taking a placebo. Another study found that voclosporin was safe even for patients who did not respond well to other treatments.

Overall, the research suggests that voclosporin is safe, with no major safety surprises. However, like any treatment, some people may experience side effects. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for lupus nephritis?

Researchers are excited about voclosporin for lupus nephritis because it offers a targeted approach that differs from standard treatments like corticosteroids and immunosuppressants. Voclosporin works by selectively inhibiting calcineurin, a protein that plays a role in activating immune cells that can damage the kidneys in lupus nephritis. This targeted action has the potential to reduce kidney inflammation more effectively and with fewer side effects compared to broader immunosuppressive therapies. Additionally, voclosporin is administered orally, which is convenient for patients. These features make it a promising option that could improve outcomes for those with lupus nephritis.

What evidence suggests that this trial's treatments could be effective for lupus nephritis?

Research has shown that voclosporin, which participants in this trial may receive, effectively treats lupus nephritis (LN). Studies have found that patients taking voclosporin experienced significant improvements in kidney function, with more achieving full recovery compared to those on a placebo. Specifically, one study found that 20% of patients on voclosporin reached full kidney recovery at six months, double the rate of the control group. These improvements in kidney health persisted for three years of treatment. Overall, voclosporin shows promise in reducing excess protein in urine and protecting kidney function in LN patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with lupus according to the 2019 criteria.

My kidney biopsy confirmed I have active lupus nephritis.

Exclusion Criteria

Clinically significant drug or alcohol abuse prior to screening

I do not have active TB nor a history of TB without taking TB prevention medication.

I have been diagnosed with cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Double-blind, placebo-controlled treatment with voclosporin or placebo

8 weeks

Treatment Period 2

Open-label treatment with increasing doses of voclosporin

8 weeks

Treatment Period 3

Continuation of open-label treatment with maximum dose of voclosporin

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Oral Capsule
• Voclosporin

Trial Overview 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.

How Is the Trial Designed?

Group I: Voclosporin treatment group 4 Experimental Treatment 1 Intervention

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

Group II: Voclosporin treatment group 3 Experimental Treatment 1 Intervention

3 capsules (23.7 mg) BID of voclosporin

Group III: Voclosporin treatment group 1 Experimental Treatment 1 Intervention

2 capsules (15.8 mg) BID of voclosporin

Group IV: Placebo treatment group 2 Placebo Group 1 Intervention

2 capsules BID of placebo

Who Is Running the Clinical Trial?

Aurinia Pharmaceuticals Inc.

Lead Sponsor

Trials

18

Recruited

3,700+

Labcorp Corporation of America Holdings, Inc

Industry Sponsor

Trials

22

Recruited

3,600+

Labcorp Drug Development, Inc.

Industry Sponsor

Trials

11

Recruited

540+

Labcorp Drug Development Inc

Industry Sponsor

Trials

17

Recruited

2,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37466424/

Safety and Efficacy of Long-Term Voclosporin Treatment ... Improved proteinuria persisted across three years of treatment, leading to more frequent complete renal responses in patients treated with voclosporin (50.9% vs ...

2. thelancet.com thelancet.com/article/S0140-6736(21)00578-X/fulltext

Efficacy and safety of voclosporin versus placebo for lupus ... There was a significant increase in 6-month complete renal response rates for the voclosporin group dosed 23·7 mg twice daily compared with placebo. The 23·7 mg ...

3. jrheum.org jrheum.org/content/52/Suppl_1/157

voclosporin was effective and safe in treating lupus ... Voclosporin in combination with MMF was effective in reducing proteinuria and preserving renal function in LN patients, even in those who have failed prior ...

4. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.42657

Safety and Efficacy of Long‐Term Voclosporin Treatment for ... Improved proteinuria persisted across three years of treatment, leading to more frequent complete renal responses in patients treated with ...

5. journals.lww.com journals.lww.com/cjasn/fulltext/2024/03000/efficacy_of_voclosporin_in_proliferative_lupus.9.aspx

Efficacy of Voclosporin in Proliferative Lupus Nephritis wit... Compared with the control arm (10%), a greater proportion of patients treated with voclosporin achieved a complete renal response at 6 months (20%, OR, 2.18; 95 ...

6. lupus.bmj.com lupus.bmj.com/content/11/Suppl_2/A85.1

1007 Voclosporin for lupus nephritis Conclusions Voclosporin was well-tolerated over three years of treatment. The significant reductions in proteinuria initially achieved in AURORA ...