NCT07378527 Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
| NCT ID | NCT07378527 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Chronic Spontaneous Urticaria (CSU) |
| Study Type | INTERVENTIONAL |
| Enrollment | 344 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2028-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: * 1\. Men and women aged 18 to 75 years. * 2\. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines. * 3\. CSU duration for ≥ 6 months prior to randomization. * 4\. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form. Exclusion Criteria: * 1\. Having the other medical conditions related to CSU or other skin diseases/conditions. * 2\. Potential medical conditions or issues. * 3\. Pregnant female subjects or lactating female subjects. * 4\. The investigator determines that the subject is unsuitable for participating in this study for any reason.