Clinical Trials List
Protocol Number299IG301
NCT Number(ClinicalTrials.gov Identfier)NCT06935357
Active
2025-04-01 - 2029-09-30
Phase III
Recruiting8
ICD-10N05.9
Unspecified nephritic syndrome with unspecified morphologic changes
ICD-10N06.9
Isolated proteinuria with unspecified morphologic lesion
ICD-10N07.9
Hereditary nephropathy, not elsewhere classified with unspecified morphologic lesions
ICD-10N15.9
Renal tubulo-interstitial disease, unspecified
ICD-9583.9
Nephritis and nephropathy, not specified as acute or chronic, with unspecified pathological lesion in kidney
A phase 3, randomized, double-blind, placebo-controlled trial (PREVAIL) of felzartamab in adult patients with IgA nephropathy (IgAN).
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Sponsor
Biogen Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tso-Hsiao Chen Division of Nephrology
- Yueh-Lin Wu Division of Nephrology
- Chung-Te Liu Division of Nephrology
- 楊韻紅 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kun-Hua Tu Division of Nephrology
- Cheng-Chia Lee Division of Nephrology
- Wen-Hung Huang Division of Nephrology
- Ya-Chung Tian Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mei-Yi Wu Division of Nephrology
- Li-Yee Hong Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
- 林冠宏 Division of Nephrology
- YUNG-HO HSU Division of Nephrology
- I-WEN WU Division of Nephrology
- 高芷華 Division of Nephrology
- 洪冠予 Division of Nephrology
- Chia-Te Liao Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yi wen chiu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Immunoglobulin A nephropathy (IgA nephropathy, IgAN)
Objectives
To evaluate the efficacy of felzartamab versus placebo in reducing proteinuria in adult patients with IgA nephropathy (IgAN).
Test Drug
Felzartamab
Active Ingredient
Felzartamab
Dosage Form
048
Dosage
325 mg
Endpoints
To assess the percent change in proteinuria from baseline to Week 36, as measured by the urine protein-to-creatinine ratio (UPCR) obtained from 24-hour urine samples.
Inclution Criteria
In the opinion of the investigator, the participant is capable of and willing to provide written informed consent and comply with study procedures. The participant must sign and date the informed consent form (ICF) prior to performing any study-specific screening procedures.
Participants assigned male or female at birth, ≥18 years of age at the time of signing the ICF.
Biopsy-confirmed diagnosis of IgA nephropathy (IgAN) within 10 years prior to signing the ICF. For participants with type 2 diabetes mellitus, a biopsy confirmation of IgAN within 24 months prior to ICF signing is required. Only participants whose biopsy does not show features of diabetic nephropathy are eligible for this study. If no biopsy specimen is available within these timeframes, a repeat biopsy may be performed after consultation with the medical monitor. The biopsy report and de-identified protected health information must be provided to the sponsor or an independent nephropathologist for review.
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² at screening, calculated using the 2021 CKD-EPI creatinine equation. For the exploratory cohort, eGFR ≥ 20 and < 30 mL/min/1.73 m² is acceptable.
Proteinuria ≥ 1.0 g/day or UPCR ≥ 0.8 g/g, assessed from an appropriately collected 24-hour urine sample during screening and analyzed by the central laboratory.
Clinically stable for at least 12 weeks prior to screening on the maximum tolerated or approved dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB), or documented intolerance to these medications. If intolerant, this must be discussed with the medical monitor prior to randomization. Participants may also receive SGLT2 inhibitors (SGLT2i), approved endothelin receptor antagonists (ERA) for IgAN, and/or mineralocorticoid receptor antagonists (MRA), provided the doses have been stable for at least 12 weeks prior to screening. During the trial, participants should continue these background therapies at a stable dose, unless discontinuation or dose adjustment is warranted due to an adverse event (AE). Participants receiving sparsentan must not concurrently use ACEI or ARB therapy.
Blood pressure ≤ 150/90 mmHg, based on the average of three readings taken at the first screening visit. If elevated, one repeat measurement may be performed during screening at the investigator’s discretion.
Must have adequate venous access for blood collection and intravenous administration of the investigational product (IP) as outlined in the protocol.
Women of childbearing potential (WOCBP) are eligible only if not pregnant or breastfeeding, and must agree to adhere to the contraceptive guidance throughout the study or for at least 90 days after the last IP dose if they withdraw early.
Male participants who are post-pubertal and not permanently sterile (via bilateral orchiectomy) must agree to abstain from sexual intercourse or use highly effective contraception during the study and for at least 90 days after the last IP dose if they withdraw early. Highly effective methods include complete abstinence from heterosexual intercourse, vasectomy with documented azoospermia at screening, sexual partner of non-childbearing potential, or condom use (male) with spermicide combined with a female partner’s use of hormonal contraception, intrauterine device (IUD), or barrier method.
Male participants must agree not to donate sperm, and female participants must agree not to donate ova during the study or for 90 days after the last IP dose (if withdrawn early).
As assessed by the investigator, all participants are recommended to be up to date with routine vaccinations per local public health authority guidance within 4 weeks prior to the first IP dose. Live attenuated vaccines are prohibited within 4 weeks prior to or during screening.
Participants assigned male or female at birth, ≥18 years of age at the time of signing the ICF.
Biopsy-confirmed diagnosis of IgA nephropathy (IgAN) within 10 years prior to signing the ICF. For participants with type 2 diabetes mellitus, a biopsy confirmation of IgAN within 24 months prior to ICF signing is required. Only participants whose biopsy does not show features of diabetic nephropathy are eligible for this study. If no biopsy specimen is available within these timeframes, a repeat biopsy may be performed after consultation with the medical monitor. The biopsy report and de-identified protected health information must be provided to the sponsor or an independent nephropathologist for review.
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² at screening, calculated using the 2021 CKD-EPI creatinine equation. For the exploratory cohort, eGFR ≥ 20 and < 30 mL/min/1.73 m² is acceptable.
Proteinuria ≥ 1.0 g/day or UPCR ≥ 0.8 g/g, assessed from an appropriately collected 24-hour urine sample during screening and analyzed by the central laboratory.
Clinically stable for at least 12 weeks prior to screening on the maximum tolerated or approved dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB), or documented intolerance to these medications. If intolerant, this must be discussed with the medical monitor prior to randomization. Participants may also receive SGLT2 inhibitors (SGLT2i), approved endothelin receptor antagonists (ERA) for IgAN, and/or mineralocorticoid receptor antagonists (MRA), provided the doses have been stable for at least 12 weeks prior to screening. During the trial, participants should continue these background therapies at a stable dose, unless discontinuation or dose adjustment is warranted due to an adverse event (AE). Participants receiving sparsentan must not concurrently use ACEI or ARB therapy.
Blood pressure ≤ 150/90 mmHg, based on the average of three readings taken at the first screening visit. If elevated, one repeat measurement may be performed during screening at the investigator’s discretion.
Must have adequate venous access for blood collection and intravenous administration of the investigational product (IP) as outlined in the protocol.
Women of childbearing potential (WOCBP) are eligible only if not pregnant or breastfeeding, and must agree to adhere to the contraceptive guidance throughout the study or for at least 90 days after the last IP dose if they withdraw early.
Male participants who are post-pubertal and not permanently sterile (via bilateral orchiectomy) must agree to abstain from sexual intercourse or use highly effective contraception during the study and for at least 90 days after the last IP dose if they withdraw early. Highly effective methods include complete abstinence from heterosexual intercourse, vasectomy with documented azoospermia at screening, sexual partner of non-childbearing potential, or condom use (male) with spermicide combined with a female partner’s use of hormonal contraception, intrauterine device (IUD), or barrier method.
Male participants must agree not to donate sperm, and female participants must agree not to donate ova during the study or for 90 days after the last IP dose (if withdrawn early).
As assessed by the investigator, all participants are recommended to be up to date with routine vaccinations per local public health authority guidance within 4 weeks prior to the first IP dose. Live attenuated vaccines are prohibited within 4 weeks prior to or during screening.
Exclusion Criteria
Secondary IgA nephropathy (IgAN) as determined by the investigator, defined as the presence of any other systemic disease that may cause IgA deposition (e.g., lupus nephritis [LN], IgA vasculitis, ankylosing spondylitis, dermatitis herpetiformis, chronic liver disease, inflammatory bowel disease, or celiac disease).
Rapidly progressive IgAN, defined as a >50% decline in eGFR within 3 months that cannot be explained by changes in renin-angiotensin system (RAS) blockade or other factors.
Nephrotic syndrome presumed to be caused by minimal change disease (MCD).
Concurrent progressive glomerulonephritis or non-immune glomerular disease, such as diabetic nephropathy.
Presence of nephrotic syndrome at screening.
History of type 1 diabetes mellitus.
Type 2 diabetes mellitus with HbA1c > 8% at screening, or renal biopsy showing diabetic nephropathy, or history of diabetic microvascular or macrovascular complications (e.g., diabetic retinopathy, peripheral neuropathy).
Any diagnosed or suspected immunosuppressive or immunodeficiency condition, such as asplenia, HIV infection, primary immunodeficiency, or organ/bone marrow transplantation (except corneal transplantation).
Current or anticipated requirement for renal dialysis.
Clinically significant findings on 12-lead ECG at screening, as determined by the investigator.
Planned renal, bone marrow, or organ transplantation during the study.
Current or expected use of prohibited concomitant therapies, except for SGLT2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), and mineralocorticoid receptor antagonists (MRA) as specified in inclusion criterion 6.
Use of immunosuppressants or other immunomodulatory agents within 4 months prior to screening (or 12 months for rituximab), including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids (>7.5 mg/day prednisone/prednisolone or equivalent).
Current treatment with oral budesonide. Participants who discontinued budesonide ≥4 months before screening may be eligible.
History of anti-CD38 antibody therapy.
Current use of complement inhibitors (e.g., iptacopan) or B-cell–targeted therapies (e.g., sibeprenlimab, atacicept). Participants with prior exposure may be eligible after discussion with the medical monitor.
Use of herbal or traditional medicines with immunosuppressive or immunomodulatory effects (e.g., Tripterygium wilfordii) is prohibited during the study. These agents must be discontinued ≥6 weeks before screening. If uncertain whether a concomitant agent has such effects, consult the medical monitor.
Use of traditional Chinese medicine decoctions or injections during screening.
Tonsillectomy within 6 months prior to screening.
Clinically significant active infection, history of recurrent clinically significant infections, laboratory findings consistent with active infection at screening, or receipt of IV anti-infective therapy (antibacterial, antiviral, or antifungal) within 14 weeks or oral anti-infective therapy within 8 weeks prior to randomization. Participants with a history of opportunistic infections are excluded.
Active or latent tuberculosis (TB) detected by positive QuantiFERON-TB Gold Plus test, medical history, examination, or chest X-ray, unless the participant is on isoniazid prophylaxis. Participants with latent TB (positive QuantiFERON but negative X-ray) must start prophylaxis ≥4 weeks before first IP dose and complete therapy per local guidelines.
Participants with a history of adequately treated active or latent TB may be eligible if documentation of prior full treatment is provided. These participants need not repeat QuantiFERON testing but must have a chest X-ray within 4 months prior to screening and obtain medical monitor approval before enrollment.
Vaccination with any live or live-attenuated vaccine within 30 days prior to screening, or planned receipt during the study or within 90 days after the last IP dose (whichever is longer).
Known or suspected hypersensitivity to felzartamab or its excipients (L-histidine, sucrose, polysorbate 20).
History of anaphylaxis, hypersensitivity, or severe allergic reaction to any monoclonal antibody.
Exclusionary laboratory results at screening:
a. Hemoglobin < 90 g/L
b. Platelets < 100 × 10⁹/L
c. Absolute neutrophil count < 1.5 × 10⁹/L
d. White blood cell count < 3.0 × 10⁹/L
e. Total bilirubin > 1.5 × upper limit of normal (ULN)
f. AST > 1.5 × ULN
g. ALT > 1.5 × ULN
h. Alkaline phosphatase > 3 × ULN
i. Participants with Gilbert’s syndrome may be enrolled.
j. Serum IgG < 6.0 g/L at screening.
Positive serologic test for HIV, or history of HIV, hepatitis C, or hepatitis B infection.
Participants with HCV antibody positive but RNA PCR negative may be included.
Participants with HBV DNA PCR positive and/or HBsAg positive are excluded.
Participants HBcAb positive must have undetectable HBV DNA PCR and agree to antiviral prophylaxis.
History of malignancy within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or non-melanoma skin cancers.
Pregnant or breastfeeding, or planning pregnancy during the study.
Participation in another clinical trial of an investigational drug or device within 30 days prior to screening or within 5 half-lives of the prior investigational product (whichever is longer).
Participants previously treated with complement inhibitors, anti-APRIL, or anti-APRIL/BAFF therapies may be eligible after discussion with the medical monitor.
Participants previously treated with dual endothelin–angiotensin receptor antagonists (DEARA, e.g., sparsentan) must have discontinued the drug ≥12 weeks prior to screening.
Concurrent participation in another interventional clinical trial involving an investigational product or device during this study.
Any clinically significant underlying condition that, in the investigator’s opinion, could interfere with study participation, pose a safety risk, or confound interpretation of study results, including general noncompliance with treatment.
Major surgery, severe trauma, or fracture within 3 months prior to first IP dose, or planned surgery within 1 month after study completion.
Blood donation or loss ≥ 450 mL within 8 weeks prior to first IP dose, or intention to donate blood before study completion.
Clinically significant drug or alcohol abuse within 2 years prior to screening, as determined by the investigator.
Positive urine drug screen for substances of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opioids), unless prescribed at screening.
Rapidly progressive IgAN, defined as a >50% decline in eGFR within 3 months that cannot be explained by changes in renin-angiotensin system (RAS) blockade or other factors.
Nephrotic syndrome presumed to be caused by minimal change disease (MCD).
Concurrent progressive glomerulonephritis or non-immune glomerular disease, such as diabetic nephropathy.
Presence of nephrotic syndrome at screening.
History of type 1 diabetes mellitus.
Type 2 diabetes mellitus with HbA1c > 8% at screening, or renal biopsy showing diabetic nephropathy, or history of diabetic microvascular or macrovascular complications (e.g., diabetic retinopathy, peripheral neuropathy).
Any diagnosed or suspected immunosuppressive or immunodeficiency condition, such as asplenia, HIV infection, primary immunodeficiency, or organ/bone marrow transplantation (except corneal transplantation).
Current or anticipated requirement for renal dialysis.
Clinically significant findings on 12-lead ECG at screening, as determined by the investigator.
Planned renal, bone marrow, or organ transplantation during the study.
Current or expected use of prohibited concomitant therapies, except for SGLT2 inhibitors (SGLT2i), endothelin receptor antagonists (ERA), and mineralocorticoid receptor antagonists (MRA) as specified in inclusion criterion 6.
Use of immunosuppressants or other immunomodulatory agents within 4 months prior to screening (or 12 months for rituximab), including but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids (>7.5 mg/day prednisone/prednisolone or equivalent).
Current treatment with oral budesonide. Participants who discontinued budesonide ≥4 months before screening may be eligible.
History of anti-CD38 antibody therapy.
Current use of complement inhibitors (e.g., iptacopan) or B-cell–targeted therapies (e.g., sibeprenlimab, atacicept). Participants with prior exposure may be eligible after discussion with the medical monitor.
Use of herbal or traditional medicines with immunosuppressive or immunomodulatory effects (e.g., Tripterygium wilfordii) is prohibited during the study. These agents must be discontinued ≥6 weeks before screening. If uncertain whether a concomitant agent has such effects, consult the medical monitor.
Use of traditional Chinese medicine decoctions or injections during screening.
Tonsillectomy within 6 months prior to screening.
Clinically significant active infection, history of recurrent clinically significant infections, laboratory findings consistent with active infection at screening, or receipt of IV anti-infective therapy (antibacterial, antiviral, or antifungal) within 14 weeks or oral anti-infective therapy within 8 weeks prior to randomization. Participants with a history of opportunistic infections are excluded.
Active or latent tuberculosis (TB) detected by positive QuantiFERON-TB Gold Plus test, medical history, examination, or chest X-ray, unless the participant is on isoniazid prophylaxis. Participants with latent TB (positive QuantiFERON but negative X-ray) must start prophylaxis ≥4 weeks before first IP dose and complete therapy per local guidelines.
Participants with a history of adequately treated active or latent TB may be eligible if documentation of prior full treatment is provided. These participants need not repeat QuantiFERON testing but must have a chest X-ray within 4 months prior to screening and obtain medical monitor approval before enrollment.
Vaccination with any live or live-attenuated vaccine within 30 days prior to screening, or planned receipt during the study or within 90 days after the last IP dose (whichever is longer).
Known or suspected hypersensitivity to felzartamab or its excipients (L-histidine, sucrose, polysorbate 20).
History of anaphylaxis, hypersensitivity, or severe allergic reaction to any monoclonal antibody.
Exclusionary laboratory results at screening:
a. Hemoglobin < 90 g/L
b. Platelets < 100 × 10⁹/L
c. Absolute neutrophil count < 1.5 × 10⁹/L
d. White blood cell count < 3.0 × 10⁹/L
e. Total bilirubin > 1.5 × upper limit of normal (ULN)
f. AST > 1.5 × ULN
g. ALT > 1.5 × ULN
h. Alkaline phosphatase > 3 × ULN
i. Participants with Gilbert’s syndrome may be enrolled.
j. Serum IgG < 6.0 g/L at screening.
Positive serologic test for HIV, or history of HIV, hepatitis C, or hepatitis B infection.
Participants with HCV antibody positive but RNA PCR negative may be included.
Participants with HBV DNA PCR positive and/or HBsAg positive are excluded.
Participants HBcAb positive must have undetectable HBV DNA PCR and agree to antiviral prophylaxis.
History of malignancy within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or non-melanoma skin cancers.
Pregnant or breastfeeding, or planning pregnancy during the study.
Participation in another clinical trial of an investigational drug or device within 30 days prior to screening or within 5 half-lives of the prior investigational product (whichever is longer).
Participants previously treated with complement inhibitors, anti-APRIL, or anti-APRIL/BAFF therapies may be eligible after discussion with the medical monitor.
Participants previously treated with dual endothelin–angiotensin receptor antagonists (DEARA, e.g., sparsentan) must have discontinued the drug ≥12 weeks prior to screening.
Concurrent participation in another interventional clinical trial involving an investigational product or device during this study.
Any clinically significant underlying condition that, in the investigator’s opinion, could interfere with study participation, pose a safety risk, or confound interpretation of study results, including general noncompliance with treatment.
Major surgery, severe trauma, or fracture within 3 months prior to first IP dose, or planned surgery within 1 month after study completion.
Blood donation or loss ≥ 450 mL within 8 weeks prior to first IP dose, or intention to donate blood before study completion.
Clinically significant drug or alcohol abuse within 2 years prior to screening, as determined by the investigator.
Positive urine drug screen for substances of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opioids), unless prescribed at screening.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
454 participants
