A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)

Conditions

• Immunoglobulin A Nephropathy (IgAN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Felzartamab — DRUG
  Administered IV
• Placebo — DRUG
  Administered IV

Study Details

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. 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.

Key Dates

Start date

May 8, 2025

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Jun 5, 2029

Study Design

Enrollment

454 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Participants will receive several intravenous (IV) doses of felzartamab.
• Placebo Comparator: Cohort 2
  Participants will receive several IV doses of placebo.
• Experimental: Cohort 3
  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.
• Placebo Comparator: Cohort 4
  Participants with an eGFR ≥ 20 and \<30 mL/min/1.73m\^2 will receive several IV doses of placebo.

Primary Outcome Measure

Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR) [ Time Frame: Baseline up to Week 36 ]

Central Contacts

• US Biogen Clinical Trial Center
  866-633-4636
  [email protected]
• Global Biogen Clinical Trial Center
  [email protected]

Locations (28)

Find similar trials in Little Rock, AR

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