Felzartamab for IgA Nephropathy

(PREVAIL Trial)

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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