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NCT Number: NCT07378527

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

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

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Key information

Conditions

Chronic Spontaneous Urticaria (CSU) Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bengbu Medical University First Affiliated Hospital, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICP-332 Tablets

Drug

ICP-332 will be administered as tablet for 12 weeks

ICP-332 placebo Tablets

Drug

ICP-332 placebo will be administered as tablet for 12 weeks

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jianzhong Zhang

CONTACT

[email protected]

+86-010-88325474

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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