Felzartamab for IgA Nephropathy

(PREVAIL Trial)

Recruiting at 114 trial locations

Overseen By Global Biogen Clinical Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Biogen

Must be taking: ACEI, ARB, SGLT2is, ERAs

Must not be taking: Immunosuppressives, Oral budesonide

Disqualifiers: Secondary IgAN, Nephrotic syndrome, Diabetes, Immunodeficient, 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

Duration: 24 weeks

454 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how felzartamab affects individuals with IgA nephropathy, a kidney disease characterized by protein in the urine due to kidney damage. Researchers seek to measure changes in urine protein levels over 36 weeks with this treatment. Participants will receive either felzartamab or a placebo (a substance with no active medicine) through IV infusions. Ideal candidates for the trial have confirmed IgA nephropathy and noticeable proteinuria (high protein levels in their urine) and have been stable on their current kidney medications. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

Will I have to stop taking my current medications?

Participants should stay on stable doses of their current medications, like ACE inhibitors or ARBs, for the whole study unless there's a side effect. If you're taking sparsentan, you can't use ACE inhibitors or ARBs at the same time.

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

In earlier studies, researchers tested felzartamab in people to assess its safety. Research has shown that most participants generally tolerate it well. Some individuals reported mild side effects at the injection site, such as redness or swelling, which usually resolve quickly.

Serious side effects have been rare, but they have occurred in some cases. Felzartamab is in a later stage of testing, indicating some confidence in its safety. However, as with any treatment, individual reactions can vary. Those considering joining a trial should discuss the possible risks and benefits with their doctor.

Why do researchers think this study treatment might be promising for IgA nephropathy?

Felzartamab is unique because it targets CD38, a protein found on certain immune cells, which plays a role in the inflammation and kidney damage seen in IgA Nephropathy. Unlike standard treatments like corticosteroids and immunosuppressants, which broadly suppress the immune system, felzartamab offers a more targeted approach, potentially reducing side effects. Researchers are excited about this treatment because it promises a more precise intervention in the immune system, which could lead to better kidney health with fewer complications.

What evidence suggests that felzartamab might be an effective treatment for IgA nephropathy?

Research has shown that felzartamab may help treat IgA nephropathy, a type of kidney disease. In this trial, some participants will receive felzartamab, while others will receive a placebo. Studies found that patients taking felzartamab experienced a quick and lasting decrease in the amount of protein in their urine within 3 to 6 months. This decrease continued for several months, indicating better kidney health. Additionally, patients maintained stable kidney function for over 18 months. These results suggest that felzartamab could effectively lower protein in the urine and possibly improve kidney function over time. ^{1 2 3 4 5}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

Adults with IgA Nephropathy (IgAN), confirmed by biopsy within the last 10 years, who have protein in their urine due to kidney damage. They must have a certain level of kidney function and be on stable doses of specific blood pressure medications or treatments for at least 12 weeks prior to joining.

Inclusion Criteria

My kidney function, based on a specific test, is within the required range.

I have protein levels in my urine of 1.0g/day or a UPCR of ≥0.8.

My kidney disease (IgAN) was confirmed by a biopsy within the last 10 years, or within the last 2 years if I have type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive felzartamab or placebo as intravenous (IV) infusions

24 weeks

Multiple visits for IV infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

80 weeks

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Felzartamab

Trial Overview The study tests felzartamab's effect on reducing protein in urine over 36 weeks compared to a placebo. Participants will receive IV infusions without knowing if they're getting the real drug or placebo. The trial includes screening, treatment for 24 weeks, and an extended follow-up period totaling about two years.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Participants with an estimated glomerular filtration rate (eGFR) ≥ 20 and \<30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) will receive several IV doses of felzartamab.

Group II: Cohort 1 Experimental Treatment 1 Intervention

Participants will receive several intravenous (IV) doses of felzartamab.

Group III: Cohort 2 Placebo Group 1 Intervention

Participants will receive several IV doses of placebo.

Group IV: Cohort 4 Placebo Group 1 Intervention

Participants with an eGFR ≥ 20 and \<30 mL/min/1.73m\^2 will receive several IV doses of placebo.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Human Immunology Biosciences, Inc. (HI-Bio)

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40581166/

Randomized, double-blind, placebo-controlled phase 2a ... Conclusions: Treatment with felzartamab results in sustained reduction of proteinuria, suggesting disease improvement. Further evidence is needed to understand ...

2. kidney-international.org kidney-international.org/article/S0085-2538(25)00488-0/fulltext

Randomized, double-blind, placebo-controlled phase 2a ... Treatment with felzartamab versus placebo led to rapid (within 3–6 months) reduction in least-squares mean UPCR sustained at nine months (placebo, –5.7%; 2-dose ...

3. investors.biogen.com investors.biogen.com/news-releases/news-release-details/biogen-presents-positive-results-phase-2-ignaz-study-felzartamab

Biogen Presents Positive Results from Phase 2 IGNAZ ... The results showed substantial reductions in proteinuria, stabilization of kidney function, and sustained treatment effect more than 18 months ...

4. journals.lww.com journals.lww.com/jasn/fulltext/2024/10001/felzartamab_for_iga_nephropathy__final_results_of.322.aspx

Felzartamab for IgA Nephropathy: Final Results of the ... Among felzartamab arms, IgA reductions were rapid and durable (lasting 19 months after the last dose); IgG recovered by 6−9 months. Efficacy in Part 2 was ...

5. asn-online.org asn-online.org/about/press/releases/ASN_PR_20241025_Shah10.17FINAL.pdf

How the Novel Antibody Felzartamab Impacts IgA ... Patients who received 9 doses over a 6-month treatment period maintained Gd-IgA1 reduction for up to 9 months off-treatment.