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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

344

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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)

February 13, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

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