This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with CSU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
subcutaneous injection
subcutaneous injection
Tianjin Academy of Traditional Chinese Medicine Affiliate Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGChange from the baseline in 7-day urticaria activity score (UAS7) at 16 weeks of treatment (W16)
UAS7 is a verified and recognized Patient Reported Outcomes(PRO) scale for evaluating the activity of CSU, consisting of 7-day hives-severity score and 7-day itch-severity score (ISS7), ranging from 0 to 42 points. UAS7 score \< 7 indicates low urticaria activity, UAS7 score \> 28 suggests high urticaria activity and severe condition.
Time frame: Up to 16 weeks
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