This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy. The study has two parts. Part one is dose escalation part, and Part two is dose expansion part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
In accordance with the protocol
In accordance with the protocol
In accordance with the protocol
Incidence of adverse events in Part 1
Time frame: Up to 24 weeks
Overall Remission Rate at week 52 in Part 2
Participants with overall remission are those achieving either complete remission or partial remission
Time frame: week 52
Blood drug concentration of JMT-601 in Part 1
Time frame: week 24
Immunological remission in the anti-PLA2R antibody positive population in Part 1
Proportion of anti-PLA2R antibody-positive participants achieving immunological remission
Time frame: week 12, 24
Changes in anti-PLA2R antibody titers from baseline in anti-PLA2R antibody positive population in Part 1
Time frame: week 24
Overall Remission Rate in Part 1
Time frame: weeks 12, 24
Complete Remission Rate in Part 1
A complete remission is defined as UPCR (based on 24-hour urine collection) ≤ 0.3, and a stable eGFR (remaining unchanged or decreasing by ≤ 15% compared with the baseline)
Time frame: weeks 12, 24
ADA (anti-drug antibody) positivity rate of JMT-601 in Part 1
Time frame: week 24
Nab (Neutralizing antibody) positivity rate of JMT-601 in Part 1
Time frame: week 24
Complete remission rate in Part 2
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Complete remission is defined as UPCR (based on 24-hour urine collection) ≤ 0.3, and a stable eGFR (remaining unchanged or decreasing by ≤ 15% compared with the baseline).
Time frame: week 24, 52, 76, 104
Overall remission rate in Part 2
Participants with overall remission are those achieving either complete remission or partial remission. Partial remission is defined as a reduction of proteinuria to 0.3-3.5 g/24 h and 50% lower than baseline with stable renal function.
Time frame: week 24, 52, 76, 104
Relapse rate in Part 2
A relapse is defined as reappearance of UPCR (based on 24-hour urine collection) \> 3.5 after complete or partial remission
Time frame: week 52, 76, 104
Time to first complete remission in Part 2
Time frame: week 104
Time to first overall remission in Part 2
Time frame: week 104
Time to first relapse in Part 2
Time frame: week 104
Change of urine protein from baseline in Part 2
Time frame: week 12, 24, 52, 76, 104
Change of estimated Glomerular Filtration Rate (eGFR) from baseline in Part 2
Time frame: week 12, 24, 52, 76, 104
Immunological response in the anti-PLA2R antibody positive population in Part 2
Time frame: week 12, 24, 52, 76, 104
Blood drug concentration of JMT-601 in Part 2
Time frame: week 104
ADA (anti-drug antibody) positivity rate of JMT-601 in Part 2
Time frame: week 104
Nab (Neutralizing antibody) positivity rate of JMT-601 in Part 2
Time frame: week 104
Adverse Events (AEs) in Part 2
Time frame: week 104