Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
Phase 2/3 – combined trial
Conditions:
Chronic Spontaneous Urticaria (CSU)
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
trial.available_in:
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Overview
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
Who can participate
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.
Interventions
ICP-332 Tablets
DRUG
ICP-332 placebo Tablets
DRUG
ICP-332 Tablets
DRUG
Locations
30
China (30)
Peking University People's Hospital
Beijing , Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing , Beijing Municipality
NOT_YET_RECRUITING
Bengbu Medical University First Affiliated Hospital
Bengbu , Anhui
NOT_YET_RECRUITING
The First Hospital of Jilin University
Changchun , Jilin
NOT_YET_RECRUITING
Xiangya hospital central south university
Changsha , Hunan
NOT_YET_RECRUITING
Chengdu Second People's Hospital
Chengdu , Sichuan
NOT_YET_RECRUITING
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
Chengdu , Sichuan
NOT_YET_RECRUITING
The First Affiliated Hospital of Chongqing Medical University
Chongqing , Chongqing Municipality
NOT_YET_RECRUITING
Chongqing Traditional Chinese Medicine Hospital
Chongqing , Chongqing Municipality
NOT_YET_RECRUITING
First Affiliated Hospital of Fujian Medical University
Fuzhou , Fujian
NOT_YET_RECRUITING
Dermatology Hospital of Southern Medical University
Guangzhou , Guangdong
NOT_YET_RECRUITING
Hangzhou Third People's Hospital
Hangzhou , Zhejiang
NOT_YET_RECRUITING
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
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