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Taking peoplePhase 2/3

ICP-332 for chronic spontaneous urticaria not controlled by usual antihistamines

Tests ICP-332 in adults whose chronic spontaneous urticaria persists despite antihistamine treatment.

Key facts

Who runs it
Beijing InnoCare Pharma Tech Co., Ltd.
Where
China30 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
Status
Recruiting
Phase
Phase 2/3
People taking part
344 people, planned
Started
13 Feb 2026
Expected to end
Sept 2028
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ICP-332 Tablets
  • ICP-332 placebo Tablets
Record updated
21 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate to severe chronic spontaneous urticaria (long-lasting hives with no known trigger). Their hives are not well controlled by second generation H1-antihistamines.

Age
18 to 75 years
Sex
Men and women
Disease stage
Moderate to severe chronic spontaneous urticaria, lasting ≥ 6 months before randomization.
Earlier treatment
Hives not well controlled by second generation H1-antihistamines (allergy pills).

Main reasons for not taking part

  • Other medical conditions related to the hives, or other skin diseases
  • Other possible medical conditions or issues
  • Pregnant women
  • Breastfeeding women
  • The study doctor decides you cannot take part for any reason

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 6 groups in the trial

  • ICP-332 dose A（Phase2）Treatment being tested

    ICP-332 will be administered as tablet

    Treatment: ICP-332 Tablets

  • ICP-332 dose B（Phase2）Treatment being tested

    ICP-332 will be administered as tablet

    Treatment: ICP-332 Tablets

  • ICP-332 dose C（Phase2）Treatment being tested

    ICP-332 will be administered as tablet

    Treatment: ICP-332 Tablets

  • Placebo（Phase2）Placebo, for comparison

    ICP-332 Placebo will be administered as tablet

    Treatment: ICP-332 placebo Tablets

  • ICP-332 dose A or dose B or dose C（Phase3）Treatment being tested

    ICP-332 will be administered as tablet

    Treatment: ICP-332 Tablets

  • Placebo（Phase3）Placebo, for comparison

    ICP-332 Placebo will be administered as tablet

    Treatment: ICP-332 placebo Tablets

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
ICP-332 for chronic spontaneous urticaria not controlled by usual antihistaminesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT07378527, who can take part
Record updated
21 April 2026