Chronic urticaria
Conditions
Interventions
Excellent efficacy group and poor efficacy group:None
Sponsors
Hangzhou Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient is aged 18 or above and has been clinically diagnosed with chronic spontaneous urticaria complicated by chronic inducible urticaria (meeting the criteria of the 2022 edition of the Chinese Guidelines for the Diagnosis and Treatment of Urticaria); 2. The patient still has symptoms (defined as UCT < 12) after receiving standard - dose anti - histamine treatment for 1 - 2 weeks or double - dose anti - histamine treatment (combined with another anti - histamine) for 1 - 2 weeks; 3. The patient needs and is willing to receive remibrutinib treatment; 4. The patient agrees to sign the informed consent form to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Severe allergy to remibrutinib or its excipients; 2. Simultaneous participation in an interventional clinical study; 3. Judged by the researcher to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving UCT>=12 at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in UCT/UAS 7/ISS7/HSS7;Proportion of patients with UAS7=0 at week 12;Types and incidence of adverse events (AE) and serious adverse events (SAE) during treatment and follow-up;Proportion of UCT=16 and UCT>=12;Proportion of patients with UCT>=12 and UCT=16 at week 12;Relapse rate and median time to relapse at 1/2/3 months after remibrutinib discontinuation;Number of weeks without angioedema from baseline to weeks 1, 4, 8, 12, 24, and 52;Week 4, 12, 24, 52: DLQI=0/1 patients; Mean absolute change in DLQI from baseline; | — |
Countries
China
Contacts
Public ContactYe Yujian
Hangzhou Third People's Hospital
Outcome results
None listed