Felzartamab for Lupus Nephritis

Recruiting at 46 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: HI-Bio, A Biogen Company

Disqualifiers: Rapidly progressive glomerulonephritis, Dialysis, Kidney transplant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It mentions that participants will receive felzartamab plus standard of care, which might include your current treatments.

What makes the drug Felzartamab unique for treating lupus nephritis?

Felzartamab is unique because it targets CD38, a protein on the surface of certain immune cells, which is different from other treatments like belimumab that target B-cell activating factors. This novel mechanism may offer a new approach for patients who do not respond well to existing therapies. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

HI-Bio, A Biogen Company

Eligibility Criteria

This trial is for people with Lupus Nephritis who have tried at least one standard treatment without success. They must have a specific type of kidney inflammation diagnosed by biopsy within the last year, protein in their urine, and kidneys that are still working moderately well. People can't join if they have very fast-worsening kidney disease, more than half of their kidney filters scarred, are on or will need dialysis soon, or had an organ transplant.

Inclusion Criteria

Your kidney function is good, with an eGFR of at least 45 mL/min/1.73 m^2.

I have been diagnosed with SLE according to the 2019 EULAR/ACR criteria.

My kidney biopsy shows I have a specific type of lupus nephritis.

Exclusion Criteria

More than half of the kidney samples taken show scarring.

My kidney disease is worsening quickly.

I have had or am planning to have an organ transplant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive felzartamab plus standard of care for lupus nephritis

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Felzartamab (Monoclonal Antibodies)

Trial Overview The study is testing Felzartamab alongside usual treatments for Lupus Nephritis to see how safe it is and how well patients tolerate it. Participants will receive Felzartamab plus the standard care that's typically given for this condition.

Participant Groups

Group I: Felzartamab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

HI-Bio, A Biogen Company

Lead Sponsor

Trials

7

Recruited

300+

HI-Bio

Lead Sponsor

Trials

6

Recruited

180+

Findings from Research

In a study of 45 Chinese patients with refractory lupus nephritis, belimumab treatment resulted in a 55.6% overall renal response rate, with 13.3% achieving complete renal response and 42.2% achieving partial renal response after 24 weeks.

Belimumab was found to be safe, with only 3 reported adverse events (2 infections and 1 allergy) and no serious events, while also allowing 20% of patients to reduce their prednisone dosage significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to belimumab among patients with refractory lupus nephritis: a real-world observational retrospective multicenter study. Zhang, S., Qiu, Q., Zeng, S., et al.[2023]

In a small study of four patients with lupus nephritis, the combination of voclosporin and belimumab showed promising results, allowing for a reduction in glucocorticoid use and decreased proteinuria.

None of the patients experienced serious infections during the treatment, suggesting a favorable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Using Both Voclosporin and Belimumab in Four Patients With Lupus Nephritis. Baum, R., Geetha, D., Fatola, A., et al.[2023]

Mizoribine (MZR) treatment in 13 Japanese patients with lupus nephritis led to a significant decrease in urinary protein and an increase in creatinine clearance, indicating improved kidney function.

The study found that maintaining a peak MZR blood concentration above 0.66 microg/ml was associated with better clinical outcomes, suggesting that optimal dosing is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mizoribine therapy for patients with lupus nephritis: the association between peak mizoribine concentration and clinical efficacy. Kuroda, T., Hirose, S., Tanabe, N., et al.[2017]

Over half of patients with Systemic Lupus Erythematosus develop lupus nephritis, which is diagnosed through clinical signs and confirmed by renal biopsy, highlighting the importance of early detection and treatment.

Recent studies suggest that new treatments, such as Obinutuzumab and Belimumab, which target B lymphocytes, along with the calcineurin inhibitor Voclosporin, can improve renal responses in lupus nephritis when used alongside standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The treatment of lupus nephritis, between consolidated strategies and new therapeutic options: a narrative review]. Fontana, F., Alfano, G., Cappelli, G.[2021]

In a study of 1844 nephritis-naïve patients with systemic lupus erythematosus (SLE), low-dose intravenous belimumab (1 mg/kg monthly) significantly reduced the risk of de novo renal flares by nearly 3-fold compared to placebo.

Subcutaneous belimumab (200 mg weekly) also showed a protective effect against renal flares, while the standard approved dose of intravenous belimumab (10 mg/kg monthly) did not demonstrate clear protective benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Belimumab on Preventing de novo Renal Lupus Flares. Parodis, I., Lindblom, J., Cetrez, N., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Response to belimumab among patients with refractory lupus nephritis: a real-world observational retrospective multicenter study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment Using Both Voclosporin and Belimumab in Four Patients With Lupus Nephritis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Mizoribine therapy for patients with lupus nephritis: the association between peak mizoribine concentration and clinical efficacy. [2017]

4. Italy pubmed.ncbi.nlm.nih.gov

[The treatment of lupus nephritis, between consolidated strategies and new therapeutic options: a narrative review]. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Belimumab on Preventing de novo Renal Lupus Flares. [2023]