Clinical Trials List
Protocol Number299IG301
NCT Number(ClinicalTrials.gov Identfier)NCT06935357
Active
2025-04-01 - 2029-09-30
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.
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Sponsor
Biogen Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/06
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chung-Te Liu Division of Nephrology
- Yueh-Lin Wu Division of Nephrology
- Tso-Hsiao Chen 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
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mei-Yi Wu Division of Nephrology
- I-WEN WU Division of Nephrology
- 林冠宏 Division of Nephrology
- Li-Yee Hong Division of Nephrology
- 高芷華 Division of Nephrology
- YUNG-HO HSU Division of Nephrology
- Yu-Wei Chen Division of Nephrology
- Chia-Te Liao Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Guan-Hsing Chen
Co-Principal Investigator
- Ya-Chung Tian Division of Nephrology
- Kun-Hua Tu Division of Nephrology
- Wen-Hung Huang Division of Nephrology
- Cheng-Chia Lee Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
The percentage change in proteinuria from baseline to week 36 was assessed based on the urine protein/creatinine ratio (UPCR) measurement of 24-hour urine samples.
Objectives
Evaluate the efficacy of felzartamab compared to placebo in treating proteinuria in adult patients with IgAN.
Test Drug
Felzartamab
Active Ingredient
Felzartamab
Dosage Form
Injectable frozen powder
Dosage
325 mg
Endpoints
The percentage change in proteinuria from baseline to week 36 was assessed based on the urine protein/creatinine ratio (UPCR) measurement of 24-hour urine samples.
Inclution Criteria
1. Subjects must be able and willing to provide a signed participant consent form and comply with the trial procedures, as determined by the administrator. A participant must sign and date a participant consent form (ICF) before any trial-specific screening procedure is performed.
2. Subjects must be designated male or female at birth and be ≥18 years of age at the time of signing the ICF.
3. Subjects must have been diagnosed with IgAN by biopsy within 10 years prior to signing the ICF. For subjects with type 2 diabetes, a biopsy confirming the IgAN diagnosis must be performed within 24 months prior to signing the ICF. Only subjects with no features of diabetic nephropathy on their biopsy are eligible for inclusion in this trial. If no biopsy specimen is available within this timeframe, a biopsy may be performed again after consultation with the medical monitor. The biopsy report and masked protected health information must be provided to the trial commissioner or an independent renal pathologist for review.
4. Estimated glomerular filtration rate (eGFR) calculated using the 2021 Chronic Kidney Disease Epidemiology (CKD-EPI) creatinine formula at screening: ≥ 30 mL/min/1.73 m². For the exploratory cohort, eGFR ≥ 20 and < 30 mL/min/1.73 m² is acceptable.
5. Assess using 24-hour urine samples appropriately collected during screening, analyzed by a central laboratory, with proteinuria ≥ 1.0 g/day or UPCR ≥ 0.8 g/g.
6. Prior to screening, be clinically stable for at least 12 weeks after treatment with the maximum tolerated or maximum approved dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), or be intolerant to ACEI or ARB. If intolerant, this must be discussed with the medical monitor prior to randomization. Subjects may also use sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) approved for the treatment of IgAN, provided that the dose has been stable for at least 12 weeks prior to screening. Subjects should continue to receive these background medications at stable doses during the trial. Once an ICF is signed, the dose during the trial cannot be changed or the medication discontinued unless such medication is considered to be associated with an adverse event (AE). Subjects using sparsentan must not use ACEIs or ARBs concurrently.
7. Blood pressure, calculated as the average of three readings from the initial screening follow-up visit, should be ≤ 150/90 mmHg. If blood pressure is elevated, it may be rechecked once during screening at the discretion of the administrator.
8. Intravenous access must be available for blood sample collection and intravenous administration of the study drug (IP) according to the trial protocol.
9. Women of fertility are eligible to participate only if they are not pregnant and are not breastfeeding. Female participants must agree to follow contraceptive guidelines throughout the trial, or, if a participant withdraws from the trial early, to follow contraceptive guidelines for at least 90 days after the last dose of IP.
10. Male participants considered fertile after puberty must agree to abstain from sex or use highly effective contraception during the trial, or, if a participant discontinues IP early, for at least 90 days after the last dose of IP. Highly effective contraception includes abstinence from heterosexual intercourse, vasectomy with a negative semen analysis at screening, a partner who is infertile, or the use of spermicide condoms (for men) and the use of hormonal contraception or an intrauterine device (IUD) or barrier methods by the female partner.
11. During the trial or for 90 days after the last dose of IP (if withdrawing from the trial early), male participants must agree not to donate sperm, and female participants must agree not to donate eggs.
12. Based on the assessment of the trial administrator, it is recommended that all participants receive the latest full set of vaccines within 4 weeks prior to the first dose of IP, as required by their local national or regional public health authority. Receivement of the live attenuated vaccine within 4 weeks prior to or during screening is prohibited.
2. Subjects must be designated male or female at birth and be ≥18 years of age at the time of signing the ICF.
3. Subjects must have been diagnosed with IgAN by biopsy within 10 years prior to signing the ICF. For subjects with type 2 diabetes, a biopsy confirming the IgAN diagnosis must be performed within 24 months prior to signing the ICF. Only subjects with no features of diabetic nephropathy on their biopsy are eligible for inclusion in this trial. If no biopsy specimen is available within this timeframe, a biopsy may be performed again after consultation with the medical monitor. The biopsy report and masked protected health information must be provided to the trial commissioner or an independent renal pathologist for review.
4. Estimated glomerular filtration rate (eGFR) calculated using the 2021 Chronic Kidney Disease Epidemiology (CKD-EPI) creatinine formula at screening: ≥ 30 mL/min/1.73 m². For the exploratory cohort, eGFR ≥ 20 and < 30 mL/min/1.73 m² is acceptable.
5. Assess using 24-hour urine samples appropriately collected during screening, analyzed by a central laboratory, with proteinuria ≥ 1.0 g/day or UPCR ≥ 0.8 g/g.
6. Prior to screening, be clinically stable for at least 12 weeks after treatment with the maximum tolerated or maximum approved dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), or be intolerant to ACEI or ARB. If intolerant, this must be discussed with the medical monitor prior to randomization. Subjects may also use sodium-glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) approved for the treatment of IgAN, provided that the dose has been stable for at least 12 weeks prior to screening. Subjects should continue to receive these background medications at stable doses during the trial. Once an ICF is signed, the dose during the trial cannot be changed or the medication discontinued unless such medication is considered to be associated with an adverse event (AE). Subjects using sparsentan must not use ACEIs or ARBs concurrently.
7. Blood pressure, calculated as the average of three readings from the initial screening follow-up visit, should be ≤ 150/90 mmHg. If blood pressure is elevated, it may be rechecked once during screening at the discretion of the administrator.
8. Intravenous access must be available for blood sample collection and intravenous administration of the study drug (IP) according to the trial protocol.
9. Women of fertility are eligible to participate only if they are not pregnant and are not breastfeeding. Female participants must agree to follow contraceptive guidelines throughout the trial, or, if a participant withdraws from the trial early, to follow contraceptive guidelines for at least 90 days after the last dose of IP.
10. Male participants considered fertile after puberty must agree to abstain from sex or use highly effective contraception during the trial, or, if a participant discontinues IP early, for at least 90 days after the last dose of IP. Highly effective contraception includes abstinence from heterosexual intercourse, vasectomy with a negative semen analysis at screening, a partner who is infertile, or the use of spermicide condoms (for men) and the use of hormonal contraception or an intrauterine device (IUD) or barrier methods by the female partner.
11. During the trial or for 90 days after the last dose of IP (if withdrawing from the trial early), male participants must agree not to donate sperm, and female participants must agree not to donate eggs.
12. Based on the assessment of the trial administrator, it is recommended that all participants receive the latest full set of vaccines within 4 weeks prior to the first dose of IP, as required by their local national or regional public health authority. Receivement of the live attenuated vaccine within 4 weeks prior to or during screening is prohibited.
Exclusion Criteria
1. Secondary IgAN as determined by the trial administrator, i.e., the presence of any other systemic disease that could trigger IgA deposition (e.g., lupus nephritis [LN], IgA vasculitis, ankylosing spondylitis, herpetic dermatitis, chronic liver disease, inflammatory bowel disease, diarrhea).
2. History of worsening IgAN, defined as a decrease in eGFR >50% every 3 months that cannot be explained by changes in the renin-angiotensin system (RAS) blockade or other factors.
3. Nephrotic syndrome presumed to be caused by minimal change disease (MCD).
4. Concomitant other progressive glomerulonephritis or non-immune glomerular diseases, such as diabetic nephropathy.
5. Nephrotic syndrome present at screening.
6. History of type 1 diabetes.
7. Type 2 diabetes mellitus with HbA1c > 8% at screening, or histological examination showing signs of diabetic nephropathy, a history of diabetic microvascular or macrovascular disease (e.g., diabetic retinopathy, peripheral neuropathy).
8. Any diagnosed or suspected immunosuppressive or immunodeficiency condition, such as asplenia, HIV, primary immunodeficiency, organ or bone marrow transplantation, excluding corneal transplantation.
9. Currently or expected to require kidney dialysis.
10. At screening, a clinically significant finding on a 12-lead electrocardiogram (ECG) as determined by the trial administrator.
11. Planned kidney, bone marrow, or organ transplantation during the trial.
12. Currently receiving or known to require contraindicated therapies and concurrent treatments, excluding SGLT2i, ERA, and MRA, as described in inclusion criterion 6.
13. Prior to screening, the patient has received immunosuppressant or other immunomodulatory therapy, such as, 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).
14. The patient is currently receiving oral budesonide therapy. Patients who have discontinued this therapy ≥4 months prior to screening may be eligible.
15. The patient has a history of anti-CD38 antibody therapy.
16. The patient is currently using complement inhibitors (such as iptacopan) or B-cell modulatory therapy (such as sibeprenlimab, atacicept, etc.). Subjects with a history of prior use of these medications may be eligible for inclusion in this trial after discussion with the medical monitor.
17. Adjunctive medications with immunosuppressive or immunomodulatory effects, including but not limited to Tripterygium wilfordii, are prohibited throughout the trial. Patients should discontinue these medications at least 6 weeks prior to screening. If there are any questions regarding the use of adjunctive medications without immunosuppressive or immunomodulatory effects, please consult the medical monitor.
18. Traditional Chinese medicine decoctions or injections are prohibited during screening.
19. Subjects who have undergone tonsillectomy within the past 6 months.
20. Subjects with clinically significant active infection, a history of known recurrent clinically significant infection, or laboratory test results consistent with active infection at screening time, or who have received intravenous anti-infective drugs (antibacterial, antiviral, or antifungal) within 14 weeks prior to randomization or oral anti-infective drugs within 8 weeks prior to randomization. Subjects with a history of opportunistic infections are excluded.
21. Active or latent tuberculosis (TB) is detected based on a positive QuantiFERON-TB Gold Plus test, medical history, examination, and chest X-ray (if isoniazid is not being used for prophylactic treatment). Subjects with evidence of latent TB based on QuantiFERON-TB Gold testing but no evidence of active infection (e.g., negative X-ray) should begin treatment at least 4 weeks before the first dose of IP, and then continue and complete the full course of treatment according to local latent TB guidelines.
22. For potential subjects with a history of receiving adequate treatment under local standard care for active or latent TB, the administrator must verify and document prior adequate anti-TB treatment. These potential subjects do not need to undergo QuantiFERON testing but still need to have a chest X-ray within 4 months of screening and must be approved for eligibility by the trial commissioner's medical monitor prior to enrollment. Potential subjects with a completed and documented TB prophylaxis or treatment protocol may be enrolled in the trial.
23. Received any type of live or attenuated vaccine within 30 days prior to screening, or is scheduled to receive any type of live or attenuated vaccine during the trial or within 90 days after the last IP dose (whichever is longer).
24. Known or suspected allergy to felzartamab or its excipients (L-histidine, sucrose, polysorbate 20).
25. History of systemic anaphylactic reactions, allergic reactions, or other serious anaphylactic reactions to any monoclonal antibody.
26. Laboratory test values excluded at screening:
a. Heme < 90 g/L.
b. Thrombocytopenia: Platelets < 100.0 × 10⁹/L.
c. Neutropenia: Neutrophils < 1.5 × 10⁹/L.
d. Leukopenia: White blood cells < 3.0 × 10⁹/L.
e. Total bilirubin > 1.5 × Upper Limit of Normal (ULN)
f. Aspartate transaminase (AST) > 1.5 × ULN
g. Alanine transaminase (ALT) > 1.5 × ULN
h. Alkaline phosphatase > 3.0 × ULN
i. Potential subjects with Gilbert's syndrome may be included in the trial.
j. Low gamma globulin levels: Serum IgG < 6.0 g/L at screening.
27. Positive results for human immunodeficiency virus (HIV) serological markers, or a history of HIV or hepatitis C (included if the patient has a positive hepatitis C virus [HCV] antibody test but a negative HCV RNA polymerase chain reaction [PCR] test), or a history of hepatitis B (excluded if the patient has a positive hepatitis B virus deoxyribonucleic acid [DNA] PCR test and/or a positive hepatitis B surface antigen [HBsAg] test). For patients who are positive for hepatitis B core antibody (HBc), the hepatitis B virus (HBV) DNA PCR test must be undetectable to be included. These subjects must consent to anti-HBV prophylaxis.
28. Any malignant tumor within 5 years prior to screening, excluding adequately treated cervical carcinoma in situ, basal or squamous cell carcinoma, or other non-melanoma skin cancers.
29. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the trial.
30. Subjects who are currently enrolled or have participated in a clinical device or drug trial within 30 days prior to screening or within 5 half-lives of the IP (whichever is longer). Potential subjects who meet this criterion and have received complement inhibitors, anti-APRIL, or anti-APRIL/BAFF therapy in a previous trial are eligible for enrollment, but their eligibility must be discussed with the medical monitor. Subjects who have received dual endothelin-angiotensin receptor antagonists (DEARA, such as sparsentan) are eligible for this trial, but must have discontinued DEARA for at least 12 weeks at screening.
31. Participation in other trials of the investigational drug and/or device is prohibited during the trial period.
32. Subjects with any clinically significant underlying medical condition that, in the principal investigator's opinion, may affect trial participation, pose a safety risk to the subject, or may obscure the interpretation of trial results, including overall non-adherence to investigational drug treatment.
33. History of major surgery, severe trauma, or fracture within 3 months prior to the first dose of IP, or planned surgery within 1 month after the trial's completion.
34. Donation or loss of ≥ 450 mL of blood or blood products within ≤ 8 weeks prior to the first dose of IP, or intention to donate blood before the trial's completion.
35. Clinically significant drug or alcohol abuse within 2 years prior to screening, based on the administrator's judgment.
36. Positive urine drug screening results for drug abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opioids), unless prescribed at the time of screening.
2. History of worsening IgAN, defined as a decrease in eGFR >50% every 3 months that cannot be explained by changes in the renin-angiotensin system (RAS) blockade or other factors.
3. Nephrotic syndrome presumed to be caused by minimal change disease (MCD).
4. Concomitant other progressive glomerulonephritis or non-immune glomerular diseases, such as diabetic nephropathy.
5. Nephrotic syndrome present at screening.
6. History of type 1 diabetes.
7. Type 2 diabetes mellitus with HbA1c > 8% at screening, or histological examination showing signs of diabetic nephropathy, a history of diabetic microvascular or macrovascular disease (e.g., diabetic retinopathy, peripheral neuropathy).
8. Any diagnosed or suspected immunosuppressive or immunodeficiency condition, such as asplenia, HIV, primary immunodeficiency, organ or bone marrow transplantation, excluding corneal transplantation.
9. Currently or expected to require kidney dialysis.
10. At screening, a clinically significant finding on a 12-lead electrocardiogram (ECG) as determined by the trial administrator.
11. Planned kidney, bone marrow, or organ transplantation during the trial.
12. Currently receiving or known to require contraindicated therapies and concurrent treatments, excluding SGLT2i, ERA, and MRA, as described in inclusion criterion 6.
13. Prior to screening, the patient has received immunosuppressant or other immunomodulatory therapy, such as, 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).
14. The patient is currently receiving oral budesonide therapy. Patients who have discontinued this therapy ≥4 months prior to screening may be eligible.
15. The patient has a history of anti-CD38 antibody therapy.
16. The patient is currently using complement inhibitors (such as iptacopan) or B-cell modulatory therapy (such as sibeprenlimab, atacicept, etc.). Subjects with a history of prior use of these medications may be eligible for inclusion in this trial after discussion with the medical monitor.
17. Adjunctive medications with immunosuppressive or immunomodulatory effects, including but not limited to Tripterygium wilfordii, are prohibited throughout the trial. Patients should discontinue these medications at least 6 weeks prior to screening. If there are any questions regarding the use of adjunctive medications without immunosuppressive or immunomodulatory effects, please consult the medical monitor.
18. Traditional Chinese medicine decoctions or injections are prohibited during screening.
19. Subjects who have undergone tonsillectomy within the past 6 months.
20. Subjects with clinically significant active infection, a history of known recurrent clinically significant infection, or laboratory test results consistent with active infection at screening time, or who have received intravenous anti-infective drugs (antibacterial, antiviral, or antifungal) within 14 weeks prior to randomization or oral anti-infective drugs within 8 weeks prior to randomization. Subjects with a history of opportunistic infections are excluded.
21. Active or latent tuberculosis (TB) is detected based on a positive QuantiFERON-TB Gold Plus test, medical history, examination, and chest X-ray (if isoniazid is not being used for prophylactic treatment). Subjects with evidence of latent TB based on QuantiFERON-TB Gold testing but no evidence of active infection (e.g., negative X-ray) should begin treatment at least 4 weeks before the first dose of IP, and then continue and complete the full course of treatment according to local latent TB guidelines.
22. For potential subjects with a history of receiving adequate treatment under local standard care for active or latent TB, the administrator must verify and document prior adequate anti-TB treatment. These potential subjects do not need to undergo QuantiFERON testing but still need to have a chest X-ray within 4 months of screening and must be approved for eligibility by the trial commissioner's medical monitor prior to enrollment. Potential subjects with a completed and documented TB prophylaxis or treatment protocol may be enrolled in the trial.
23. Received any type of live or attenuated vaccine within 30 days prior to screening, or is scheduled to receive any type of live or attenuated vaccine during the trial or within 90 days after the last IP dose (whichever is longer).
24. Known or suspected allergy to felzartamab or its excipients (L-histidine, sucrose, polysorbate 20).
25. History of systemic anaphylactic reactions, allergic reactions, or other serious anaphylactic reactions to any monoclonal antibody.
26. Laboratory test values excluded at screening:
a. Heme < 90 g/L.
b. Thrombocytopenia: Platelets < 100.0 × 10⁹/L.
c. Neutropenia: Neutrophils < 1.5 × 10⁹/L.
d. Leukopenia: White blood cells < 3.0 × 10⁹/L.
e. Total bilirubin > 1.5 × Upper Limit of Normal (ULN)
f. Aspartate transaminase (AST) > 1.5 × ULN
g. Alanine transaminase (ALT) > 1.5 × ULN
h. Alkaline phosphatase > 3.0 × ULN
i. Potential subjects with Gilbert's syndrome may be included in the trial.
j. Low gamma globulin levels: Serum IgG < 6.0 g/L at screening.
27. Positive results for human immunodeficiency virus (HIV) serological markers, or a history of HIV or hepatitis C (included if the patient has a positive hepatitis C virus [HCV] antibody test but a negative HCV RNA polymerase chain reaction [PCR] test), or a history of hepatitis B (excluded if the patient has a positive hepatitis B virus deoxyribonucleic acid [DNA] PCR test and/or a positive hepatitis B surface antigen [HBsAg] test). For patients who are positive for hepatitis B core antibody (HBc), the hepatitis B virus (HBV) DNA PCR test must be undetectable to be included. These subjects must consent to anti-HBV prophylaxis.
28. Any malignant tumor within 5 years prior to screening, excluding adequately treated cervical carcinoma in situ, basal or squamous cell carcinoma, or other non-melanoma skin cancers.
29. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the trial.
30. Subjects who are currently enrolled or have participated in a clinical device or drug trial within 30 days prior to screening or within 5 half-lives of the IP (whichever is longer). Potential subjects who meet this criterion and have received complement inhibitors, anti-APRIL, or anti-APRIL/BAFF therapy in a previous trial are eligible for enrollment, but their eligibility must be discussed with the medical monitor. Subjects who have received dual endothelin-angiotensin receptor antagonists (DEARA, such as sparsentan) are eligible for this trial, but must have discontinued DEARA for at least 12 weeks at screening.
31. Participation in other trials of the investigational drug and/or device is prohibited during the trial period.
32. Subjects with any clinically significant underlying medical condition that, in the principal investigator's opinion, may affect trial participation, pose a safety risk to the subject, or may obscure the interpretation of trial results, including overall non-adherence to investigational drug treatment.
33. History of major surgery, severe trauma, or fracture within 3 months prior to the first dose of IP, or planned surgery within 1 month after the trial's completion.
34. Donation or loss of ≥ 450 mL of blood or blood products within ≤ 8 weeks prior to the first dose of IP, or intention to donate blood before the trial's completion.
35. Clinically significant drug or alcohol abuse within 2 years prior to screening, based on the administrator's judgment.
36. Positive urine drug screening results for drug abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, methadone, opioids), unless prescribed at the time of screening.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
454 participants
