A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) (PREVAIL)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)
- Immunoglobulin A Nephropathy (IgAN)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Biogen
- Enrolment target
- 454
- Started
- 8 May 2025
- Main results due (estimated)
- 31 May 2027
- Study ends (estimated)
- 5 June 2029
- Allocation
- Randomized
- Design
- Parallel
- Purpose
- Treatment
- Masking
- Quadruple (participant, care provider, investigator, outcomes assessor)
- Sites
- 264 · 17 in India
- First posted
- 20 April 2025
- Registry updated
- 30 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied. Healthy volunteers are not accepted.
Age groups: adult, older adult.
These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.
Read the full eligibility criteria
Key Inclusion Criteria: * Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF. * An eGFR ≥ 30 mL/min/1.73 m\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \< 30 mL/min/1.73 m\^2 is acceptable for the cohorts 3 and 4. * 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 collection. * Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication. Key Exclusion Criteria: * Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator. * History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors. * IgAN-(MCD) variant. * Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy. * Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy). * Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants. * Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (\> 7.5 milligrams per day \[mg/d\] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids \> 7.5 mg/day prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail. * Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible. * Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded. * Hypogammaglobulinemia: serum Immunoglobin G (IgG) \< 6.0 gram per litre (g/L), at Screening. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
What this study is about
In the sponsor’s own words, from the registry.
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.
Read the detailed description
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.
Keywords: Felzartamab
What participants receive
- Experimental
Cohort 1
Participants will receive several intravenous (IV) doses of felzartamab.
Drug: Felzartamab
- Placebo comparator
Cohort 2
Participants will receive several IV doses of placebo.
Drug: 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.
Drug: Felzartamab
- Placebo comparator
Cohort 4
Participants with an eGFR ≥ 20 and \<30 mL/min/1.73m\^2 will receive several IV doses of placebo.
Drug: Placebo
Interventions
FelzartamabDrug
Also known as MOR202, MOR03087, TJ202, HIB202, BIIB148
Administered IV
PlaceboDrug
Administered IV
What the study measures
Primary outcomes
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
Time frame: Baseline up to Week 36
Secondary outcomes
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation
Time frame: Baseline up to Week 104
Percentage of Participants Achieving Complete Response (CR)
CR is defined as a UPCR value (based on 24-hour urine collection) of \< 0.5 gram per gram (g/g), a reduction in UPCR of ≥ 50%, and a stable eGFR (decrease from baseline in eGFR of ≤ 25%).
Time frame: Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Malfunction
The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. ≥ 40% Reduction in eGFR Sustained for ≥ 30 Days, 2. eGFR \<15 mL/min/1.73 m\^2 for ≥ 30 Days, 3. Undergoing Dialysis for ≥ 30 Days, 4. Undergoing Kidney Transplantation, 5. Died From Kidney Failure
Time frame: Baseline up to Week 104
Percentage of Participants Requiring Rescue Therapy
Time frame: Baseline up to Week 104
Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation
Time frame: Baseline up to Week 52
Felzartamab Serum Concentrations Over Time
Time frame: Predose and at multiple timepoints postdose up to Week 36
Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab
Time frame: Baseline up to Week 104
Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to Week 104
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations Abnormalities
Time frame: Baseline up to Week 104
Who is running it
- Lead sponsor
- Biogen
- Sponsor type
- Industry
- Responsible party
- The sponsor
- Organisation
- Biogen
- Data monitoring committee
- Yes
- US FDA-regulated drug
- Yes
- US FDA-regulated device
- No
- Sponsor's study ID
- 299IG301
- Other IDs
- 2024-519345-30-00
Medical Director
Study director
Biogen
Study sites(264)
Osmania General Hospital
Hyderabad, Andhra Pradesh, India
Recruiting
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India
Recruiting
All India Institute of Medical Sciences ( AIIMS ) - Raipur
Raipur, Chhattisgarh, India
Recruiting
Zydus Hospital
Ahmedabad, Gujarat, India
Recruiting
Muljibhai Patel Society for Research in Nephro-Urology
Nadiād, Gujarat, India
Recruiting
Manipal Hospital Bangalore
Bangalore, Karnataka, India
Recruiting
Government Medical College, Kozhikode
Kozhikode, Kerala, India
Recruiting
Seth G S Medical College and K E M Hospital
Mumbai, Maharashtra, India
Recruiting
Max Super Speciality Hospital - Saket
New Delhi, National Capital Territory of Delhi, India
Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Recruiting
King George Medical University
Lucknow, Uttar Pradesh, India
Recruiting
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Recruiting
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, India
Recruiting
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, India
Recruiting
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India
Withdrawn
Trivandrum Medical College Hospital
Trivandrum, Kerala, India
Withdrawn
Noble Hospital
Pune, Maharashtra, India
Withdrawn
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Recruiting
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, United States
Recruiting
Scripps Green Hospital
Carlsbad, California, United States
Recruiting
UCLA Health David Geffen School of Medicine
Los Angeles, California, United States
Recruiting
FOMAT Medical Research - FOMAT - PPDS
Oxnard, California, United States
Recruiting
North America Research Institute-San Dimas
San Dimas, California, United States
Recruiting
Nova Clinical Research, LLC
Bradenton, Florida, United States
Recruiting
University of Florida - Gainesville - 1600 SW Archer Rd
Gainesville, Florida, United States
Recruiting
Royal Research, Corp.
Hollywood, Florida, United States
Recruiting
Central Florida Kidney Specialists
Orlando, Florida, United States
Recruiting
CDC Research Institute, LLC
Port Saint Lucie, Florida, United States
Recruiting
The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Anointed Nephrology and HTN - SKYCRNG - PPDS
Brookhaven, Mississippi, United States
Recruiting
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, United States
Recruiting
Lifespan at Rhode Island Hospital
Providence, Rhode Island, United States
Recruiting
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Recruiting
Texas Kidney Institute - Dallas
Dallas, Texas, United States
Recruiting
Provecta Research Network
Houston, Texas, United States
Recruiting
R & H Clinical Research
Katy, Texas, United States
Recruiting
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Recruiting
Showing 40 of 264 sites, filter to narrow it down. 249 of 264 on this study are recruiting right now, and 17 are in India. A site can stop enrolling while the study as a whole is still open.
References and data sharing
- Participant data shared
- Yes
- Where
- https://vivli.org/
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Source: ClinicalTrials.gov record NCT06935357, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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