At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Felzartamab (drug), Placebo (drug)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Felzartamab — drug: Administered IV · Placebo — drug: Administered IV
- Patient visit burden
- "* In total, participants will have 17 study visits." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 454
- Started
- 2025-05-08
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for immunoglobulin a nephropathy (igan)
- • Phase3 - 454 participants
- • In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with immunoglobulin a nephropathy (igan)
Where?
- • London - St Pancras Clinical Research
- • Preston - Royal Preston Hospital - NWCRN- PPDS
- • Leicester - Leicester General Hospital
- • Sheffield - Northern General Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine...
Who cannot take part
- ✗Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading...
- ✗History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by...
- ✗IgAN-(MCD) variant.
- ✗Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
- ✗Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to...
See the full criteria
Where Is This Study? (5 UK sites)
St Pancras Clinical Research
London EC2Y 8EA, United Kingdom
Royal Preston Hospital - NWCRN- PPDS
Preston PR2 9HT, United Kingdom
Leicester General Hospital
Leicester LE5 4PW, United Kingdom
Northern General Hospital
Sheffield S5 7AU, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
How to Get in Touch
US Biogen Clinical Trial Center
Sponsor contactCONTACT
Global Biogen Clinical Trial Center
Sponsor contactCONTACT
