This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
siRNA duplex oligonucleotide
fusion protein
ADARx Clinical Site
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGADARx Clinical Site
Baotou, Inner Mongolia, China
NOT_YET_RECRUITINGADARx Clinical Site
Wuxi, Jiangsu, China
RECRUITINGEvaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.
Time frame: Part A - 24 Months and Part B - 15 months
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ADARx Clinical Site
Yantai, Shandong, China
RECRUITINGADARx Clinical Site
Beijing, China
RECRUITING