The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.
This is a Phase II open-label study to assess the safety, tolerability, Pharmacokinetics, and efficacy of surovatamig in adult participants with pMN, who are positive for anti-PLA2R antibodies and have heavy and persistent proteinuria with a high risk of progressing to end stage kidney disease. The study will be conducted across approximately 30 to 40 study sites in approximately 10 countries. The study consists of 2 parts (Part A Multiple ascending with sentinel dosing and Part B Multiple ascending doses), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Participants will receive Surovatamig subcutaneously
Research Site
Los Angeles, California, United States
NOT_YET_RECRUITINGNumber of participants with adverse events.
To assess the safety and tolerability of surovatamig on adverse events, including Adverse events, Serious adverse events, Adverse event of special interests, and Adverse events leading to discontinuation of surovatamig.
Time frame: Through study completion, an average of 2 years
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)
To assess the effect of surovatamig on proteinuria
Time frame: At 6 months
Percentage of participants achieving complete or partial remission of pMN
To evaluate the proportion of participants who achieve partial and/or complete remission
Time frame: At 24 months
Percentage of participants achieving complete remission of pMN
To evaluate the proportion of participants who achieved complete remission
Time frame: At 24 months
Percentage of participants achieving partial remission of pMN
To evaluate the proportion of participants who achieve partial remission
Time frame: At 24 months
Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection)
To assess the effect of surovatamig on proteinuria
Time frame: At 24 months
Change from baseline in anti-PLA2R antibody titer
To evaluate anti-PLA2R antibodies in blood
Time frame: At 24 months
AstraZeneca Clinical Study Information Center
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Research Site
Iowa City, Iowa, United States
Research Site
Bethesda, Maryland, United States
NOT_YET_RECRUITINGResearch Site
New York, New York, United States
NOT_YET_RECRUITINGResearch Site
Houston, Texas, United States
RECRUITINGResearch Site
Houston, Texas, United States
NOT_YET_RECRUITINGResearch Site
Ieper, Belgium
NOT_YET_RECRUITINGResearch Site
Bordeaux, France
NOT_YET_RECRUITINGResearch Site
Créteil, France
WITHDRAWNResearch Site
Lyon, France
NOT_YET_RECRUITING...and 11 more locations
Change from baseline in B-cell count in peripheral blood
To assess the effect of surovatamig by assessment of B-cell depletion in blood
Time frame: At 24 months
Time to relapse after complete or partial remission
Time to relapse after complete or partial remission
Time frame: At 24 months
Time to a ≥ 3 months sustained reduction of eGFR
Time to a sustained reduction of eGFR
Time frame: From Baseline to 24 months
Change from baseline in patient-reported experience of symptoms associated with pMN
To evaluate the change in patient-reported experience
Time frame: Through study completion, an average of 2 years
Serum PK parameters of surovatamig, AUC Area under the plasma concentration versus time curve
To characterise the PK of surovatamig
Time frame: Through study completion, an average of 2 years
Treatment-emergent ADAs
To evaluate the immunogenicity of surovatamig
Time frame: Through study completion, an average of 2 years
Serum PK parameters of surovatamig, as Cmax (Peak Plasma Concentration)
To characterise the PK of surovatamig
Time frame: Through study completion, an average of 2 years