Clinical Trials in China / NCT07378527
Recruiting
Phase 2/3
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
NCT07378527 · tracked via the Priya Life Science China tracker
Condition(s) studied
Chronic Spontaneous Urticaria (CSU)
Investigational drug(s) / intervention(s)
ICP-332 Tablets: ICP-332 will be administered as tablet for 12 weeks
ICP-332 placebo Tablets: ICP-332 placebo will be administered as tablet for 12 weeks
ICP-332 Tablets: ICP-332 will be administered as tablet for 24 weeks
Study 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 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.
Primary outcome measure(s)
- Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4. — 4 weeks
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. - Phase 3: Change from baseline in UAS7 at Week 12. — 12 weeks
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).
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| Bengbu Medical University First Affiliated Hospital | Bengbu | Anhui | Not Yet Recruiting |
| The Second Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | Not Yet Recruiting |
| Peking University People's Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 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 |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | Not Yet Recruiting |
| The Second Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Not Yet Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| Jingzhou Central Hospital | Jingzhou | Hubei | Not Yet Recruiting |
| Shiyan Taihe Hospital | Shiyan | Hubei | Not Yet Recruiting |
| Xiangya hospital central south university | Changsha | Hunan | Not Yet Recruiting |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | Not Yet Recruiting |
| Wuxi No. 2 People's Hospital | Wuxi | Jiangsu | Not Yet Recruiting |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | Not Yet Recruiting |
| The First Hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital） | Shenyang | Liaoning | Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Not Yet Recruiting |
| Jinan Central Hospital | Jinan | Shandong | Not Yet Recruiting |
| Shandong Provincial Hospital for Skin Disease, Shandong First Medical University | Jinan | Shandong | Not Yet Recruiting |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | 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 |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | Not Yet Recruiting |
| Hangzhou Third People's Hospital | Hangzhou | Zhejiang | Not Yet Recruiting |
| Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University | Hangzhou | Zhejiang | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07378527 on ClinicalTrials.gov ↗ ← All trials in China