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
RECRUITINGADARx Clinical Site
Guiyang, Guizhou, China
RECRUITINGADARx Clinical Site
Zhengzhou, Henan, China
Evaluate 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
Baotou, Inner Mongolia, China
RECRUITINGADARx Clinical Site
Wuxi, Jiangsu, China
RECRUITINGADARx Clinical Site
Yantai, Shandong, China
RECRUITINGADARx Clinical Site
Beijing, China
RECRUITINGADARx Clinical Site
Shandong, China
NOT_YET_RECRUITINGADARx Clinical Site
Shanghai, China
RECRUITINGADARx Clinical Site
Shangxi, China
NOT_YET_RECRUITING