Chronic Spontaneous Urticaria (CSU)Phase 2/3NCT07378527
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
A Phase 2/3 study testing ICP-332 Tablets in people with Chronic Spontaneous Urticaria (CSU), run by Beijing InnoCare Pharma Tech Co., Ltd. at 30 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Spontaneous Urticaria (CSU)
- What is being tested?
- ICP-332 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 30 sitesChina
- Study dates
- 13 Feb 2026to Sep 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianzhong Zhang
Cheng Zhou
- Not yet recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Aihua Wei
- Not yet recruiting
Bengbu Medical University First Affiliated Hospital
Bengbu, Anhui, 233004
Congjun Jiang
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Shan shan Li
- Not yet recruiting
Xiangya hospital central south university
Changsha, Hunan, 410008
Juan Su
- Not yet recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
bin Yin
- Not yet recruiting
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Min Zhou
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Tao Cai
- Not yet recruiting
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021
Qingchun Diao
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Niu Xiang
- Not yet recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Bin Yang
- Not yet recruiting
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009
Xingang Wu
- Not yet recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang
Liming Wu
- Not yet recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
Lihua Wang, s18953116532@163.com
- Not yet recruiting
Shandong Provincial Hospital for Skin Disease, Shandong First Medical University
Jinan, Shandong, 250022
Furen Zhang
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yi Sun
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Xiang Nong
- Not yet recruiting
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Bin Zhang
- Not yet recruiting
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
Yangfeng Ding
- Not yet recruiting
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
Shenyang, Liaoning, 110001
Zhen Wang
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xiaoguang Zhang
- Not yet recruiting
Shiyan Taihe Hospital
Shiyan, Hubei, 442000
Haixia Jing
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Jun Gu
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Shuping Guo
- Not yet recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300131
Litao Zhang
Yan Xu
- Not yet recruiting
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Ruzhi Zhang
- Not yet recruiting
Wuxi No. 2 People's Hospital
Wuxi, Jiangsu, 214001
Xiaohong Zhu
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yan Zheng
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Hongwei Liu
- Not yet recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 210031
Hui Xu
About this study
Official title: 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
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
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Being tested
- ICP-332 Tablets, ICP-332 placebo Tablets
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-332 TabletsDrug
ICP-332 will be administered as tablet for 12 weeks
ICP-332 placebo TabletsDrug
ICP-332 placebo will be administered as tablet for 12 weeks
ICP-332 TabletsDrug
ICP-332 will be administered as tablet for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| ICP-332 dose A（Phase2） | Experimental | ICP-332 will be administered as tablet Receives: Drug: ICP-332 Tablets |
| ICP-332 dose B（Phase2） | Experimental | ICP-332 will be administered as tablet Receives: Drug: ICP-332 Tablets |
| ICP-332 dose C（Phase2） | Experimental | ICP-332 will be administered as tablet Receives: Drug: ICP-332 Tablets |
| Placebo（Phase2） | Placebo comparator | ICP-332 Placebo will be administered as tablet Receives: Drug: ICP-332 placebo Tablets |
| ICP-332 dose A or dose B or dose C（Phase3） | Experimental | ICP-332 will be administered as tablet Receives: Drug: ICP-332 Tablets |
| Placebo（Phase3） | Placebo comparator | ICP-332 Placebo will be administered as tablet Receives: Drug: ICP-332 placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start13 Feb 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous Urticaria (CSU)Studies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378527
- Sponsor's protocol ID
- ICP-CL-00613
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07378527
- Acronym / sponsor ID
- ICP-CL-00613
- Conditions
- Chronic Spontaneous Urticaria (CSU)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ICP-332 dose A（Phase2） | Experimental | Drug: ICP-332 TabletsICP-332 will be administered as tablet |
| ICP-332 dose B（Phase2） | Experimental | Drug: ICP-332 TabletsICP-332 will be administered as tablet |
| ICP-332 dose C（Phase2） | Experimental | Drug: ICP-332 TabletsICP-332 will be administered as tablet |
| Placebo（Phase2） | Placebo comparator | Drug: ICP-332 placebo TabletsICP-332 Placebo will be administered as tablet |
| ICP-332 dose A or dose B or dose C（Phase3） | Experimental | Drug: ICP-332 TabletsICP-332 will be administered as tablet |
| Placebo（Phase3） | Placebo comparator | Drug: ICP-332 placebo TabletsICP-332 Placebo will be administered as tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-332 TabletsICP-332 will be administered as tablet for 12 weeks | Drug | ICP-332 dose A（Phase2）, ICP-332 dose B（Phase2）, ICP-332 dose C（Phase2） |
| ICP-332 placebo TabletsICP-332 placebo will be administered as tablet for 12 weeks | Drug | Placebo（Phase2）, Placebo（Phase3） |
| ICP-332 TabletsICP-332 will be administered as tablet for 24 weeks | Drug | ICP-332 dose A or dose B or dose C（Phase3） |
Primary outcome
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.
Time frame: 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.
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ICP-332 Tablets in people with Chronic Spontaneous Urticaria (CSU), run by Beijing InnoCare Pharma Tech Co., Ltd. at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianzhong Zhang (+86-010-88325474, rmzjz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.