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Phase 3RecruitingInterventionalNCT06935357

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)
I want to take partRefer a patient17 sites in India (14 recruiting) · 264 worldwide

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

  1. Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)

    Time frame: Baseline up to Week 36

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Percentage of Participants Requiring Rescue Therapy

    Time frame: Baseline up to Week 104

  5. Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation

    Time frame: Baseline up to Week 52

  6. Felzartamab Serum Concentrations Over Time

    Time frame: Predose and at multiple timepoints postdose up to Week 36

  7. Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab

    Time frame: Baseline up to Week 104

  8. Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)

    Time frame: Baseline up to Week 104

  9. Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities

    Time frame: Baseline up to Week 104

  10. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Time frame: Baseline up to Week 104

  11. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities

    Time frame: Baseline up to Week 104

  12. 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

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