Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines
Beijing InnoCare Pharma Tech Co., Ltd.
344 participants
Feb 13, 2026
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria4
- \. Men and women aged 18 to 75 years.
- \. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.
- \. CSU duration for ≥ 6 months prior to randomization.
- \. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.
Exclusion Criteria4
- \. Having the other medical conditions related to CSU or other skin diseases/conditions.
- \. Potential medical conditions or issues.
- \. Pregnant female subjects or lactating female subjects.
- \. The investigator determines that the subject is unsuitable for participating in this study for any reason.
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Interventions
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
Locations(30)
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NCT07378527