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

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07378527

Enrollment

344

Registered

2026-01-30

Start date

2026-02-13

Completion date

2028-09-01

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria (CSU)

Brief 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

Interventions

DRUGICP-332 Tablets

ICP-332 will be administered as tablet for 12 weeks

DRUGICP-332 placebo Tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4.	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.
Phase 3: Change from baseline in UAS7 at Week 12.	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).

Countries

China

Contacts

CONTACTJianzhong Zhang

rmzjz@126.com+86-010-88325474

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026