Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria

NCT07378527 · tracked via the Priya Life Science China tracker

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Phase

Phase 2/3

Started

2026-02-13

Last updated

2026-04-21

Condition(s) studied

Chronic Spontaneous Urticaria (CSU)

Investigational drug(s) / intervention(s)

ICP-332 TabletsICP-332 placebo TabletsICP-332 Tablets

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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