Chronic Spontaneous Urticaria
Conditions
Interventions
Non-disease-controlled study participants:Collect an additional tube of the patients peripheral blood for single-cell sequencing, in addition to the routine blood draw
CSU patients treated with omalizumab:Collect an additional tube of the patients peripheral blood for single-cell sequencing, in addition to the routine blood draw
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: CSU patients: 1. Patients with isolated inducible urticaria or isolated angioedema. 2. Concomitant cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, malignancy, or other serious internal medical conditions. 3. Concomitant severe psychiatric disorders. 4. Concurrent infection or fever within four weeks, or evidence of significant infection on complete blood count. 5. Use of systemic corticosteroids, immunosuppressants, immunoglobulins, or small-molecule drugs (e.g., BTK inhibitors) and other immune-related therapies within four weeks; 6. Pregnancy and lactation; 7. Allergic to the study drug or undergoing desensitization treatment. 8. Any other condition that, in the investigator's judgment, warr1. Diagnosis of chronic spontaneous urticaria (CSU); 2. Patients aged 18–75 years, both male and female; 3. Ineffective antihistamine treatment: defined as failure to achieve symptom relief within 4 weeks of guideline-recommended therapy with second-generation antihistamines, including up-dosing or combination therapy (Urticaria Activity Score over 7 days [UAS7] > 6 and Urticaria Control Test [UCT] = 40 IU/ml and BAT negative (-): Type I CSU; 2) Total IgE = 40 IU/ml and BAT positive (+): Type I/IIb overlap CSU; 4) Total IgE < 40 IU/ml and BAT negative (-): Non-Type I/IIb CSU.ants exclusion; Non-disease-controlled study participants: age 18-75 years, male or female.
Exclusion criteria
Exclusion criteria: CSU patients: 1. Patients with isolated inducible urticaria or isolated angioedema. 2. Concomitant cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, malignancy, or other serious internal medical conditions. 3. Concomitant severe psychiatric disorders. 4. Concurrent infection or fever within four weeks, or evidence of significant infection on complete blood count. 5. Use of systemic corticosteroids, immunosuppressants, immunoglobulins, or small-molecule drugs (e.g., BTK inhibitors) and other immune-related therapies within four weeks; 6. Pregnancy and lactation; 7. Allergic to the study drug or undergoing desensitization treatment. 8. Any other condition that, in the investigator's judgment, warrants exclusion; Non-disease control study participants: 1. Patients with acute urticaria or chronic urticaria (including chronic spontaneous urticaria, chronic inducible urticaria, or both), with or without angioedema. 2. Patients with severe allergic skin diseases or in an acute exacerbation phase, such as generalized eczema or moderate-to-severe atopic dermatitis; 3. Abnormal immunoglobulin levels (including IgE), with evaluation indicating an abnormal B-cell immunophenotype; 4. With autoimmune diseases such as systemic lupus erythematosus, Sjogren's syndrome, Hashimoto's thyroiditis, etc; 5. Concomitant cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, malignancy, or other serious internal medical conditions. 6. Concomitant severe psychiatric disorders. 7. Concurrent infection or fever within four weeks, or evidence of significant infection on complete blood count. 8. Use of systemic corticosteroids, immunosuppressants, immunoglobulins, or small-molecule drugs (e.g., BTK inhibitors) and other immune-related therapies within four weeks; 9. Pregnancy and lactation; 10. Any other condition that, in the investigator's judgment, warrants exclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urticaria control score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical information; | — |
Countries
China
Contacts
Public Contacthui Tang
Huashan Hospital, Fudan University
Outcome results
None listed