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

April 16, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
344

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jianzhong Zhang
  • Phone Number: +86-010-88325474
  • Email: rmzjz@126.com

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Not yet recruiting
        • Bengbu Medical University First Affiliated Hospital
        • Contact:
          • Congjun Jiang
      • Wuhu, Anhui, China, 241000
        • Not yet recruiting
        • The Second Affiliated Hospital of Wannan Medical College
        • Contact:
          • Ruzhi Zhang
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang
        • Contact:
          • Cheng Zhou
      • Beijing, Beijing Municipality, China, 100730
        • Not yet recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
          • Aihua Wei
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Tao Cai
      • Chongqing, Chongqing Municipality, China, 400021
        • Not yet recruiting
        • Chongqing Traditional Chinese Medicine Hospital
        • Contact:
          • Qingchun Diao
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Not yet recruiting
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Niu Xiang
    • Guangdong
      • Guangzhou, Guangdong, China, 510091
        • Not yet recruiting
        • Dermatology Hospital of Southern Medical University
        • Contact:
          • Bin Yang
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • Xiaoguang Zhang
    • Henan
      • Luoyang, Henan, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Henan University of science and technology
        • Contact:
          • Bin Zhang
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Hongwei Liu
    • Hubei
      • Jingzhou, Hubei, China, 434020
        • Not yet recruiting
        • Jingzhou Central Hospital
        • Contact:
          • Yi Sun
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Shiyan Taihe Hospital
        • Contact:
          • Haixia Jing
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Juan Su
    • Jiangsu
      • Suzhou, Jiangsu, China, 215002
        • Not yet recruiting
        • Suzhou Municipal Hospital
        • Contact:
          • Jun Gu
      • Wuxi, Jiangsu, China, 214001
        • Not yet recruiting
        • Wuxi No. 2 People's Hospital
        • Contact:
          • Xiaohong Zhu
      • Zhenjiang, Jiangsu, China, 210031
        • Not yet recruiting
        • Affiliated Hospital of Jiangsu University
        • Contact:
          • Hui Xu
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Shan shan Li
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
        • Contact:
          • Zhen Wang
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Yan Zheng
    • Shandong
      • Jinan, Shandong, China, 250013
      • Jinan, Shandong, China, 250022
        • Not yet recruiting
        • Shandong Provincial Hospital for Skin Disease, Shandong First Medical University
        • Contact:
          • Furen Zhang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200443
        • Not yet recruiting
        • Shanghai Skin Disease Hospital
        • Contact:
          • Yangfeng Ding
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
          • Shuping Guo
    • Sichuan
      • Chengdu, Sichuan, China, 610017
        • Not yet recruiting
        • Chengdu Second People's Hospital
        • Contact:
          • bin Yin
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
        • Contact:
          • Min Zhou
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300131
        • Not yet recruiting
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
          • Litao Zhang
        • Contact:
          • Yan Xu
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Xiang Nong
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • Hangzhou Third People's Hospital
        • Contact:
          • Xingang Wu
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
        • Contact:
          • Liming Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICP-332 dose A（Phase2）
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 24 weeks
Experimental: ICP-332 dose B（Phase2）
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 24 weeks
Experimental: ICP-332 dose C（Phase2）
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 24 weeks
Placebo Comparator: Placebo（Phase2）
ICP-332 Placebo will be administered as tablet
Drug: ICP-332 placebo Tablets
ICP-332 placebo will be administered as tablet for 12 weeks
Experimental: ICP-332 dose A or dose B or dose C（Phase3）
ICP-332 will be administered as tablet
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks
Drug: ICP-332 Tablets
ICP-332 will be administered as tablet for 24 weeks
Placebo Comparator: Placebo（Phase3）
ICP-332 Placebo will be administered as tablet
Drug: ICP-332 placebo Tablets
ICP-332 placebo will be administered as tablet for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-00613

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings