This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept
This Phase 2 study is to explore the effectiveness, safety and tolerability of different dosing regimens of atacicept. Regimens include monthly and weekly dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Drug: Atacicept
Vera Therapeutics
Brisbane, California, United States
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
Gd-IgA1 levels through Week 24
Time frame: Up to 24 weeks
To evaluate the safety and tolerability of atacicept at different dosing regimensT
Incidence of treatment emergent reported Adverse Events (AE)
Time frame: Baseline until end of study up to Week 24
To evaluate the effect of atacicept on serum immunoglobulins (IgA)
IgA levels through Week 24
Time frame: 24 Weeks
To evaluate the effect of atacicept on serum immunoglobulins (IgG)
IgG levels through Week 24
Time frame: 24 Weeks
To evaluate the effect of atacicept on serum immunoglobulins (IgM)
IgM levels through Week 24
Time frame: 24 Weeks
To evaluate serum PK of atacicept
Serum concentration of atacicept
Time frame: Baseline until end of study up to Week 24
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