Felzartamab for Lupus Nephritis

Recruiting at 46 trial locations

Overseen By Global Biogen Clinical Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: HI-Bio, A Biogen Company

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new drug, felzartamab, might help people with lupus nephritis (LN), a kidney condition where antibodies build up and cause damage. Researchers aim to determine if felzartamab can safely reduce protein levels in urine and improve kidney function while participants continue their regular treatment. The drug is administered intravenously in two parts, with a break in between. Individuals diagnosed with lupus, experiencing kidney issues from it, and not responding well to typical treatments might be suitable for this trial. As a Phase 1, Phase 2 trial, the study focuses on understanding how felzartamab works in people and measuring its effectiveness in a smaller group, offering participants a chance to contribute to early-stage research.

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.

Is there any evidence suggesting that felzartamab is likely to be safe for humans?

Research shows that felzartamab may help treat conditions related to antibody problems, such as lupus nephritis. In earlier studies on other conditions, patients generally tolerated felzartamab well. Some participants did experience health issues, known as adverse events, which may or may not have been caused by the drug. Researchers closely monitor these issues to ensure safety.

The treatment is now in early-stage trials for lupus nephritis. This stage is crucial for collecting safety information, indicating that felzartamab has passed some initial safety tests but requires further research. It is important to note that researchers are studying felzartamab for its potential to safely reduce kidney problems in lupus nephritis by targeting specific immune cells. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus nephritis?

Felzartamab is unique because it targets CD38, a protein involved in immune responses, which is different from most standard treatments for lupus nephritis that typically suppress the immune system more broadly. Researchers are excited about felzartamab because it offers a more targeted approach, potentially reducing side effects associated with broader immunosuppressive therapies. Additionally, the innovative dosing schedule, with two courses of intravenous doses separated by a 28-week off-treatment period, could offer patients a more convenient treatment regimen compared to ongoing, continuous therapies.

What evidence suggests that felzartamab might be an effective treatment for lupus nephritis?

Previous studies have shown that felzartamab holds promise for treating conditions like lupus nephritis. Research indicates that this treatment can significantly reduce proteinuria, which refers to excess protein in the urine, a common issue in lupus nephritis. The New England Journal of Medicine reported that patients receiving felzartamab experienced significant improvement in kidney function, with many seeing a major reduction in disease symptoms. Felzartamab targets specific immune cells, helping to lower the buildup of harmful antibodies in the kidneys. These findings suggest that felzartamab could effectively improve kidney health for people with lupus nephritis. Participants in this trial will receive two courses of multiple intravenous (IV) doses of felzartamab, separated by a 28-week off-treatment period. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

HI-Bio, A Biogen Company

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Felzartamab

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.

How Is the Trial Designed?

Group I: Felzartamab Experimental Treatment 1 Intervention

Participants will receive two courses of multiple intravenous (IV) doses of felzartamab, separated by a 28-week off-treatment period. These courses are given in Part 1 and Part 2 of the trial.

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06064929

NCT06064929 | A Study to Learn More About the Safety ... A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old · Study Overview · Contacts and Locations.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2400763

A Randomized Phase 2 Trial of Felzartamab in Antibody ... Key secondary efficacy outcomes were the resolution of antibody-mediated rejection (defined as chronic [inactive] rejection or no rejection ...

3. clinicaltrials.eu clinicaltrials.eu/inn/felzartamab/

Felzartamab – Application in Therapy and Current Clinical ... Current Clinical Trials · A study for patients with Lupus Nephritis is evaluating the safety and effectiveness of Felzartamab when added to standard treatments.

4. lupus.org lupus.org/resources/hib202101-study-of-felzartamab-in-lupus-nephritis

HIB-202-101: Study of Felzartamab in Lupus Nephritis This clinical research study, HIB-202-101 (also known as 299LE101 study), is testing an investigational drug for adults with kidney involvement ...

5. roche.com roche.com/media/releases/med-cor-2025-02-07

New England Journal of Medicine publishes new data for ... The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR).

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06064929/a-study-to-learn-more-about-the-safety-and-effects-of-felzartamab-in-adults-with-lupus-nephritis-aged-18-to-75-years-old

A Study to Learn More About the Safety and Effects ... In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN.