Actively Recruiting
Phase II/III Study of ICP-332 Tablets Versus Placebo in Moderate to Severe Chronic Spontaneous Urticaria Not Controlled by Second Generation H1-antihistamines
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-21
344
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ICP-332 in adults with moderate to severe chronic spontaneous urticaria (CSU) who have not responded well to second generation H1-antihistamines. This study is a Phase II/III randomized, double-blind, placebo-controlled trial conducted by Beijing InnoCare Pharma Tech Co., Ltd. It aims to understand how well ICP-332 works and how safe it is for this patient group. Participants will receive ICP-332 tablets or a placebo tablet. In Phase 2, there are three different doses of ICP-332 being tested against placebo, with treatment lasting 4 weeks. In Phase 3, participants receive one of the doses or placebo for 12 weeks. Some participants may receive ICP-332 tablets for up to 24 weeks as well. All treatments are given as tablets. During the study, participants will be monitored regularly with assessments focusing on changes in their Weekly Urticaria Activity Score (UAS7) at 4 weeks for Phase 2 and 12 weeks for Phase 3. Researchers will collect data on symptoms, safety, and overall health. The trial runs until September 2028, with participants involved for the full treatment period and follow-up evaluations to track effectiveness and safety.
CONDITIONS
Brief Title
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years
- Diagnosis of chronic spontaneous urticaria inadequately controlled by second generation H1-antihistamines
- Chronic spontaneous urticaria duration of 6 months or more before randomization
- Voluntary signing of informed consent before any screening or study procedures
You will not qualify if you...
- Other medical conditions related to chronic spontaneous urticaria or other skin diseases
- Presence of potential medical conditions or issues that affect participation
- Pregnant or lactating female subjects
- Investigator's determination of unsuitability for study participation for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 24 weeks
Participants receive ICP-332 tablets or placebo tablets for chronic spontaneous urticaria.
Weekly visits for up to 12 weeks with possible extension to 24 weeks
Trial Site Locations
Total: 30 locations
1
Bengbu Medical University First Affiliated Hospital
Bengbu, Anhui, China, 233004
Not Yet Recruiting
2
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241000
Not Yet Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
4
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Not Yet Recruiting
6
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China, 400021
Not Yet Recruiting
7
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Not Yet Recruiting
8
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510091
Not Yet Recruiting
9
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
10
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Not Yet Recruiting
11
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
12
Jingzhou Central Hospital
Jingzhou, Hubei, China, 434020
Not Yet Recruiting
13
Shiyan Taihe Hospital
Shiyan, Hubei, China, 442000
Not Yet Recruiting
14
Xiangya hospital central south university
Changsha, Hunan, China, 410008
Not Yet Recruiting
15
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215002
Not Yet Recruiting
16
Wuxi No. 2 People's Hospital
Wuxi, Jiangsu, China, 214001
Not Yet Recruiting
17
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 210031
Not Yet Recruiting
18
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
19
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
Shenyang, Liaoning, China, 110001
Not Yet Recruiting
20
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
21
Jinan Central Hospital
Jinan, Shandong, China, 250013
Not Yet Recruiting
22
Shandong Provincial Hospital for Skin Disease, Shandong First Medical University
Jinan, Shandong, China, 250022
Not Yet Recruiting
23
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China, 200443
Not Yet Recruiting
24
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
25
Chengdu Second People's Hospital
Chengdu, Sichuan, China, 610017
Not Yet Recruiting
26
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
27
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China, 300131
Not Yet Recruiting
28
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Not Yet Recruiting
29
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
30
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
J
Jianzhong Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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