Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICP-332 Tablets, ICP-332 placebo Tablets, ICP-332 Tablets.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria (CSU). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug ICP-332 Tablets
ICP-332 will be administered as tablet for 12 weeks - Drug ICP-332 placebo Tablets
ICP-332 placebo will be administered as tablet for 12 weeks - Drug ICP-332 Tablets
ICP-332 will be administered as tablet for 24 weeks
Primary outcome measures
- Phase 2: Change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4. [Time frame: 4 weeks]
- Phase 3: Change from baseline in UAS7 at Week 12. [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 30 centers
- Bengbu Medical University First Affiliated Hospital — Bengbu
- The Second Affiliated Hospital of Wannan Medical College — Wuhu
- Peking University People's Hospital — Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- Chongqing Traditional Chinese Medicine Hospital — Chongqing
- First Affiliated Hospital of Fujian Medical University — Fuzhou
- Dermatology Hospital of Southern Medical University — Guangzhou
- … and 22 more centers
Identifiers
NCT: NCT07378527 · ICP-CL-00613