ICP-332 for adults with moderate to severe chronic spontaneous urticaria not controlled by antihistamines

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

This study tests whether ICP-332 tablets can reduce hives and itching in adults (18–75) with moderate to severe chronic spontaneous urticaria that is not controlled by second-generation H1-antihistamines.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 30 sites (Bengbu, Anhui and 29 other locations)
• Trial ID: NCT07378527 on ClinicalTrials.gov

What this trial studies

This phase 2/3 interventional study compares ICP-332 tablets with matching placebo in adults whose CSU is inadequately controlled by second-generation H1-antihistamines. Participants must have had CSU for at least six months and meet the trial's inclusion and exclusion criteria before enrollment. Enrolled subjects are assigned to receive ICP-332 or placebo and will be followed for symptom changes and safety outcomes during the treatment period. The study is conducted at several hospital sites in China, including Peking University People's Hospital.

Who should consider this trial

Good fit: Adults aged 18 to 75 with chronic spontaneous urticaria lasting at least six months whose symptoms remain inadequately controlled by second-generation H1-antihistamines are the intended participants.

Not a fit: Pregnant or breastfeeding people, patients with other skin diseases or medical conditions listed in the exclusions, and those whose CSU is well controlled by antihistamines are unlikely to benefit from this study.

Why it matters

Potential benefit: If effective, ICP-332 could reduce hives and itching and improve quality of life for people with CSU who do not respond to standard antihistamines.

How similar studies have performed: Established biologic treatments such as anti-IgE therapy have helped many CSU patients, but ICP-332 is an investigational drug with limited prior human data.

Eligibility criteria

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.

Where this trial is running

Bengbu, Anhui and 29 other locations

• Bengbu Medical University First Affiliated Hospital — Bengbu, Anhui, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Jingzhou Central Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
• Shiyan Taihe Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
• Xiangya hospital central south university — Changsha, Hunan, China (Not_yet_recruiting)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Wuxi No. 2 People's Hospital — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital） — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Jinan Central Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Shandong Provincial Hospital for Skin Disease, Shandong First Medical University — Jinan, Shandong, China (Not_yet_recruiting)
• Shanghai Skin Disease Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Chengdu Second People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Not_yet_recruiting)
• Hangzhou Third People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jianzhong Zhang

Conditions Chronic Spontaneous Urticaria