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

InnoCare Pharma

Status and phase: Begins enrollment this month; Phase 3; Phase 2

Conditions: Chronic Spontaneous Urticaria (CSU)

Treatments: Drug: ICP-332 Tablets; Drug: ICP-332 placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07378527

ICP-CL-00613

Details and patient eligibility

About

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

Enrollment: 344 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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344 participants in 6 patient groups, including a placebo group

ICP-332 dose A（Phase2）

Experimental group

Description:

ICP-332 will be administered as tablet

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

ICP-332 dose B（Phase2）

Experimental group

Description:

ICP-332 will be administered as tablet

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

ICP-332 dose C（Phase2）

Experimental group

Description:

ICP-332 will be administered as tablet

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

Placebo（Phase2）

Placebo Comparator group

Description:

ICP-332 Placebo will be administered as tablet

Treatment:

Drug: ICP-332 placebo Tablets

ICP-332 dose A or dose B or dose C（Phase3）

Experimental group

Description:

ICP-332 will be administered as tablet

Treatment:

Drug: ICP-332 Tablets

Drug: ICP-332 Tablets

Placebo（Phase3）

Placebo Comparator group

Description:

ICP-332 Placebo will be administered as tablet

Treatment:

Drug: ICP-332 placebo Tablets