Belimumab + Voclosporin for Lupus Nephritis

(SYNERGY Trial)

Recruiting at 6 trial locations

Overseen By Julie Scoggin

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NephroNet, Inc.

Must be taking: Belimumab

Must not be taking: Cyclophosphamide, Rituximab, Atacicept, others

Disqualifiers: Dialysis, HIV, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Belimumab (a monoclonal antibody therapy) and Voclosporin (an immunosuppressant drug) with Mycophenolate Mofetil (a background therapy) can improve kidney health in people with proliferative lupus nephritis, a serious kidney condition caused by lupus. Researchers will test whether this combination helps patients achieve complete renal response, meaning improved kidney function. They will also assess if these drugs allow patients to discontinue Mycophenolate Mofetil sooner. Individuals diagnosed with lupus nephritis, particularly those experiencing flare-ups after treatment and currently managing the condition with medication, might be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment can benefit more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you must be on certain medications like Belimumab and possibly Mycophenolate Mofetil. It's best to discuss your current medications with the trial team to see if any changes are needed.

What is the safety track record for Belimumab and Voclosporin?

Research has shown that both Belimumab and Voclosporin are generally safe for people with lupus nephritis. Studies have found that Belimumab reduces the risk of kidney problems or death compared to a placebo, indicating its safety for humans. Long-term research on Voclosporin also supports its safety, showing it can be used for up to three years without major issues.

These findings provide confidence in the safety of both treatments for those considering joining a trial. While all treatments can have side effects, these studies reassure the safety of Belimumab and Voclosporin for lupus nephritis. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Belimumab and Voclosporin for lupus nephritis because these treatments offer new ways to tackle the disease. Belimumab is a monoclonal antibody that helps reduce immune system activity by targeting a protein called BLyS, which is different from standard treatments. Voclosporin, on the other hand, is a calcineurin inhibitor with a unique chemical structure that allows for better stability and potentially fewer side effects compared to older drugs like cyclosporine. Together, these drugs provide a promising combination that might improve kidney outcomes for patients with lupus nephritis more effectively than current options.

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

Research shows that using Belimumab and Voclosporin together can improve kidney health in people with lupus nephritis. In this trial, participants will be randomized into different arms to evaluate the effectiveness of these treatments. Studies have found that Belimumab increased the number of patients achieving complete kidney recovery, meaning their kidney function improved. Voclosporin also reduced the amount of protein in the urine, a key sign of kidney problems, and maintained stable kidney function. Earlier research has proven both drugs effective and safe. This combination aims to provide better results than standard treatments alone. ^{1 2 5 6 7}

Who Is on the Research Team?

James Tumlin, MD

Principal Investigator

NephroNet, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with proliferative forms of lupus glomerulopathy, specifically lupus nephritis. Participants should be suitable for treatment with Belimumab and Voclosporin alongside Mycophenolate Mofetil. Detailed inclusion and exclusion criteria are not provided but would typically involve specific health conditions and prior treatments.

Inclusion Criteria

Signed Informed Consent Form

Ability to comply with the study protocol, in the investigator's judgment

UPCR must be >750 mg/gm from a 24-hour urine collection during screening

Exclusion Criteria

Pure Class V LN on biopsy

Known hypersensitivity or contraindication to specified medications

Current or medical history of specific conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combination therapy of Belimumab and Voclosporin with Mycophenolate Mofetil, with two arms for early and extended MMF termination

12 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belimumab
• Voclosporin

Trial Overview The trial tests if combining Belimumab (BEL) and Voclosporin (VCS), with a standard therapy of Mycophenolate Mofetil (MMF), leads to better kidney recovery in lupus nephritis patients than current treatments. It also examines if this combination allows quicker MMF discontinuation.

How Is the Trial Designed?

Group I: EARLY MMF TERMINATION (90 days) ARM Active Control 1 Intervention

EARLY MMF TERMINATION (90 days) ARM in which subjects are randomized 1:1

Group II: EXTENDED MMF (360 days) ARM Active Control 1 Intervention

EXTENDED MMF TERMINATION (360 days) ARM in which subjects are randomized 1:1

Who Is Running the Clinical Trial?

NephroNet, Inc.

Lead Sponsor

Trials

3

Recruited

120+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10391090/

The effectiveness and value of belimumab and voclosporin ... Belimumab increased the complete renal response (CRR) and primary efficacy renal response (PERR) at 2 years compared with standard therapy alone.

2. icer.org icer.org/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Revised-Evidence-Report_031221.pdf

Belimumab and Voclosporin for Lupus Nephritis Efficacy of belimumab on renal outcomes in patients with systemic lupus erythematosus: A systematic review. Autoimmun Rev. 2017;16(3):287 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07225387

Safety and Efficacy of Combination Belimumab and ... This is a Phase IV, open-label, randomized trial to determine whether the combination of Belimumab (BEL) and Voclosporin (VCS), plus background ...

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

voclosporin was effective and safe in treating lupus ... Conclusions Voclosporin in combination with MMF was effective in reducing proteinuria and preserving renal function in LN patients, even in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1568997223001520

When should targeted therapies be used in the treatment of ... The effectiveness of Belimumab in patients with LN has recently been confirmed in a large real-world study [23]. The second is Voclosporin, a new calcineurin ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2001180

Two-Year, Randomized, Controlled Trial of Belimumab in ... The risk of a renal-related event or death was lower among patients who received belimumab than among those who received placebo (hazard ratio, ...

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

Safety and Efficacy of Long‐Term Voclosporin Treatment for ... Data demonstrate the safety and efficacy of long-term voclosporin treatment over three years of follow-up in patients with LN. image ...