Chronic Spontaneous Urticaria
Conditions
Interventions
Non-disease-controlled study participants:None
Group of CSU patients unresponsive to antihistamines (CSU patients with total IgE >= 40 IU/mL who are unresponsive to antihistamines and receiving omalizumab):None
Control group of CSU patients unresponsive to antihistamines (CSU patients with total IgE < 40 IU/mL who are unresponsive to antihistamines and receiving omalizumab):None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.CSU patients:Diagnosis of Chronic Spontaneous Urticaria. 2.CSU patients:Patients aged 18–75 years, regardless of sex. 3.CSU patients:Ineffectiveness of Antihistamines (Patients who fail to control symptoms with double the standard dose of second-generation antihistamines). 4.CSU patients:Assessed by a dermatology specialist and recommended for treatment with omalizumab (administered subcutaneously at a dose of 300 mg every 4 weeks for at least 3 times). 5.Non-disease-controlled study participants:Patients aged 18–75 years, male or female.
Exclusion criteria
Exclusion criteria: 1.CSU patients:Concurrent other dermatological diseases, such as generalized eczema, moderate-to-severe atopic dermatitis, etc. 2.CSU patients:Concurrent other autoimmune diseases with a definitive diagnosis, such as systemic lupus erythematosus, Sjögren's syndrome, etc. 3.CSU patients:Concurrent severe internal medical conditions, including cardiovascular and cerebrovascular diseases, severe hepatic or renal insufficiency, malignancies, etc. 4.CSU patients:Concurrent severe psychiatric or psychological disorders. 5.CSU patients:Infection, fever, or laboratory evidence of infection within the past 4 weeks. 6.CSU patients:Systemic use of corticosteroids, immunosuppressants, intravenous immunoglobulin, small-molecule drugs (e.g., BTK inhibitors), or other immune-related therapies within the past 4 weeks. 7.CSU patients:Pregnancy. 8.Non-disease control study participants: those who have had or are currently suffering from chronic allergic skin diseases or skin and appendage diseases that cannot be enrolled as assessed by the investigator, such as urticaria, generalized eczema, atopic dermatitis, psoriasis, alopecia areata, vitiligo, etc.; 9.Non-disease-controlled study participants: Abnormal immunoglobulin level detection (including IgE), assessed for abnormal status of B-cell immune classification transformation; 10.Non-disease control study participants: With autoimmune diseases such as systemic lupus erythematosus, Sjogren's syndrome, Hashimoto's thyroiditis, etc; 11.Non-disease control study participants: suffering from cardiovascular and cerebrovascular diseases, severe liver and kidney insufficiency, tumors and other serious medical diseases; 12.Non-disease control study participants: with severe mental and psychological illness; 13.Participants in non-disease control studies: co-infection, fever, and obvious signs of infection in blood routine within four weeks; 14.Non-disease control study participants: systematic use of hormones, compound glycyrrhizin, immunosuppressants, gamma globulin, small molecule drugs (such as BTK inhibitors) and other immune-related treatments within four weeks; 15.Non-disease control study participants: Pregnancy.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Urticaria Activity Score over 7 days (UAS7);Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL); | — |
Primary
| Measure | Time frame |
|---|---|
| Urticaria Control Test (UCT) score: Total score = 12: disease well controlled.; | — |
Countries
China
Contacts
Public ContactTang Hui
Huashan Hospital, Fudan University
Outcome results
None listed