RecruitingPhase 2/3

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

China344 participantsStarted 2026-02-13

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.

Timeframe: 4 weeks

Phase 3: Change from baseline in UAS7 at Week 12.

Timeframe: 12 weeks

Trial details

NCT IDNCT07378527

SponsorBeijing InnoCare Pharma Tech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Jianzhong Zhang

+86-010-88325474 rmzjz@126.com

View on ClinicalTrials.gov More Chronic Spontaneous Urticaria (CSU) trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.