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
1 other identifier
interventional
344
1 country
30
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2026
CompletedFirst Posted
Study publicly available on registry
January 30, 2026
CompletedStudy Start
First participant enrolled
February 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
April 21, 2026
January 1, 2026
2.6 years
January 23, 2026
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.
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.
4 weeks
Phase 3: Change from baseline in UAS7 at Week 12.
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).
12 weeks
Study Arms (6)
ICP-332 dose A（Phase2）
EXPERIMENTALICP-332 will be administered as tablet
ICP-332 dose B（Phase2）
EXPERIMENTALICP-332 will be administered as tablet
ICP-332 dose C（Phase2）
EXPERIMENTALICP-332 will be administered as tablet
Placebo（Phase2）
PLACEBO COMPARATORICP-332 Placebo will be administered as tablet
ICP-332 dose A or dose B or dose C（Phase3）
EXPERIMENTALICP-332 will be administered as tablet
Placebo（Phase3）
PLACEBO COMPARATORICP-332 Placebo will be administered as tablet
Interventions
ICP-332 will be administered as tablet for 12 weeks
ICP-332 placebo will be administered as tablet for 12 weeks
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Bengbu Medical University First Affiliated Hospital
Bengbu, Anhui, 233004, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Shiyan Taihe Hospital
Shiyan, Hubei, 442000, China
Xiangya hospital central south university
Changsha, Hunan, 410008, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002, China
Wuxi No. 2 People's Hospital
Wuxi, Jiangsu, 214001, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 210031, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
Shenyang, Liaoning, 110001, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shandong Provincial Hospital for Skin Disease, Shandong First Medical University
Jinan, Shandong, 250022, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300131, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009, China
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2026
First Posted
January 30, 2026
Study Start
February 13, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
April 21, 2026
Record last verified: 2026-01