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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• 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
• 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

Study contacts

• Study coordinator: Jianzhong Zhang
• Email: rmzjz@126.com
• Phone: +86-010-88325474

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Different forms of IgE in health and disease.

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• CM512 injection for adults with chronic spontaneous urticaria

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• SKINERGY: deep biomarker profiling of immune-driven skin diseases in dermatology clinics

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.