Clinical Trials List
2025-06-13 - 2030-06-30
Phase III
Recruiting10
ICD-10N05.9
Unspecified nephritic syndrome with unspecified morphologic changes
ICD-9583.0
Nephritis and nephropathy, not specified as acute or chronic, with lesion of proliferative glomerulonephritis
An Open-label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants with Primary Membranous Nephropathy (PMN) [PROMINENT]
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Sponsor
Biogen Idec Research Limited
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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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 楊韻紅 無
- Chung-Te Liu 無
- Yuh-Mou Sue 無
- YUNG-HO HSU 無
- Yueh-Lin Wu 無
- Tso-Hsiao Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 呂悅安 無
- 鄭雅蓮 無
- Cheng-Chia Lee 無
- Guan-Hsing Chen 無
- 陳佳晉 無
- 塗貽然 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 蔡尚峰 無
- TUNG-MIN YU 無
- Ming-Ju Wu 無
- 徐佳鈿 無
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
- 施宏謀 無
- 林承叡 無
- Chih-Jen Wu 無
- 潘吉豐 無
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
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
defined as a urine protein to creatinine ratio (UPCR) ≤ 0.5 g/g
(based on a 24-hour collection), with stable estimated glomerular
filtration rate (eGFR) [eGFR decrease from baseline ≤ 15%], and
serum albumin > 3.5 g/dL.
Inclution Criteria
1. Ability to understand the purpose and risks of the study, to provide signed informed
consent, and to authorize the use of confidential health information in accordance with
national and local privacy regulations.
2. Assigned male at birth or nonpregnant, nonlactating participants assigned female at birth,
18 to 80 years of age inclusive (≥ 19 years of age for applicable countries) at the time of
signing the ICF.
3. Diagnosed with PMN in need of IST according to the Investigator’s clinical judgment.
The diagnosis of PMN must be documented with the presence of nephrotic syndrome,
and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or
within 5 years of signing the ICF (see kidney biopsy exception below for participants
positive for anti-PLA2R antibodies). For these patients, the biopsy report with redacted
protected health information must be available to be reviewed by the Sponsor or an
independent nephropathologist. If the participant requires a kidney biopsy during
Screening, medical monitor approval must be obtained and all other eligibility criteria
should be reviewed to ensure that the participant is otherwise eligible prior to performing
the kidney biopsy.
• Kidney biopsy exception for anti-PLA2R antibody positive participants:
Participants who are positive for anti-PLA2R antibodies and have not had a kidney
biopsy performed within 5 years of signing the ICF, may be eligible for the study
without undergoing a kidney biopsy based on medical monitor review confirming
normal eGFR, presence of nephrotic syndrome, hypoalbuminemia, positive anti-
PLA2R antibody test (defined as an anti-PLA2R antibody titer > 20 RU/mL), and
documentation provided by the Investigator that the work-up for secondary causes of
MN was negative with no identifiable secondary causes.
4. Meets one of the following:
a. Newly diagnosed PMN, defined as having never received IST for PMN in the
past.
b. Relapsed PMN, defined as documented achievement of CR or PR after treatment
with an IST for PMN followed by reappearance of nephrotic range proteinuria
(UPCR ≥ 3.0 g/g from a 24-hour urine collection or proteinuria ≥ 3.5 g/24 h).
5. Participants with type 2 diabetes mellitus may be eligible only if a kidney biopsy is
performed within 12 months prior to Screening and demonstrates PMN without any
evidence of diabetic kidney disease, and Investigator provides documentation that type 2
diabetes mellitus is controlled as determined by:
a. Glycated hemoglobin (HbA1c) < 8.0% or 64 mmol/mol at Screening, and
b. No known history of diabetic retinopathy, and
c. No known history of peripheral neuropathy.
If the participant requires a kidney biopsy during Screening, medical monitor approval
must be obtained and all other eligibility criteria should be reviewed to ensure that the
participant is otherwise eligible prior to performing the kidney biopsy during Screening.
6. Participants must be up to date on all cancer screenings per local guidelines of standard
of care at Screening.
7. Participants must be on the maximally approved dose or maximally tolerated dose of
ACEI or ARB for at least 3 months prior to Screening. Participants not on the maximally
approved dose of RAAS inhibition may be enrolled provided there is documented
intolerance to maximal RAAS inhibition (e.g., development of postural hypotension,
lightheadedness, hyperkalemia, etc).
8. If receiving a sodium-glucose cotransporter-2 inhibitor (SGLT2i), must be on a stable
dose for at least 3 months prior to Screening.
9. An eGFR ≥ 50 mL/min/1.73 m² at Screening (Chronic Kidney Disease – Epidemiology
Collaboration [CKD-EPI] 2021 formula). Alternatively, participants with an eGFR > 30
and < 50 mL/min/1.73 m² can be included provided an interstitial fibrosis and tubular
atrophy (IFTA) score of < 25% in a kidney biopsy is histologically documented; for this
purpose, a biopsy at Screening or an archival biopsy acquired within 12 months prior to
the start of Screening is needed.
10. A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria
≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best
supportive care for at least 3 months prior to signing the ICF.
11. No evidence of ≥ 50% reduction in proteinuria during the previous 6 months prior to
randomization.
12. Systolic BP < 140 mmHg and diastolic BP < 90 mmHg obtained after 5 minutes of rest
from the average of 3 readings at the Screening visit. If the BP is elevated, it may be
repeated once during the Screening period.
13. Must have venous access sufficient to allow for blood sampling and IV administration of
study drug as per the protocol.
14. Meet the following TB screening criteria:
a. No evidence of active TB or inadequately treated TB as evidenced by 1 of the
following:
i. A negative QuantiFERON test or equivalent assay reported by the central
laboratory at Screening or within 90 days prior to randomization for
participants re-screening.
OR
ii. A history of fully treated active or latent TB according to local standard of
care. Investigator must verify adequate previous anti-TB treatment and
provide documentation; these participants do not require QuantiFERON
testing and eligibility must be approved by the Sponsor prior to enrollment in
the study.
Exclusion Criteria
1. Secondary cause of MN (e.g., malignancies, medications, SLE, hepatitis B, hepatitis C,
etc).
2. Severe renal impairment defined as an eGFR ≤30 mL/min/1.73m2 at Screening or
including the need for dialysis or renal replacement therapy.
3. Concomitant renal disease other than PMN (e.g., diabetic renal disease, lupus nephritis,
IgAN).
4. Refractory to previous use of cyclophosphamide or anti-CD20 treatments for PMN,
defined as never having achieved PR or CR of nephrotic syndrome following treatment.
5. History of major surgery, severe trauma, or bone fracture within 3 months prior to first
dose of study treatment or planned surgery 1 month after the EOS.
6. Screening laboratory values are any of the following:
a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 × ULN.
b. Alkaline phosphatase > 2.0 × ULN.
c. Total bilirubin > 1.5 × ULN (an isolated increase in bilirubin in participants with
known Gilbert’s syndrome is not a reason for exclusion).
d. Amylase or lipase > 2 × ULN.
e. Platelet count < 100 × 103/µL.
f. Hemoglobin < 8.5 g/dL (participants receiving erythropoiesis-stimulating agents such
as erythropoietin to meet the criterion are allowed).
g. White blood cell (WBC) count < 3.0 × 103/L.
h. Absolute neutrophil count (ANC) < 1.5 × 103/L.
i. CD19+ B-cells < 5 cells/L or below the assay-specific limit of quantitation,
whichever is greater.
j. Serum IgG ≤ 4.0 g/L.
k. Positive hepatitis B surface antigen or positive hepatitis B core antibody or HBV
DNA greater than or equal to the LLOQ.
l. Positive hepatitis C antibody (HCAb) or hepatitis C virus (HCV) ribonucleic acid
(RNA) greater than or equal to the LLOQ.
m. Positive human immunodeficiency virus (HIV) serology.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
180 participants
