The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
344
ICP-332 will be administered as tablet for 12 weeks
ICP-332 placebo will be administered as tablet for 12 weeks
ICP-332 will be administered as tablet for 24 weeks
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42 (highest urticaria severity), and a minimum possible score of 0.
Time frame: 4 weeks
Phase 3: Change from baseline in UAS7 at Week 12.
The Weekly Urticaria Activity Score (UAS7) is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The possible range of the UAS7 score is 0 - 42 (highest hives and itch severity).
Time frame: 12 weeks
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