acute urticaria
Conditions
Interventions
Test group:Antihistamines in combination with omalizumab for injection were administered
Sponsors
The first hospital of hebei medical university
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 12--75 years, either gender; 2.Diagnosed with acute urticaria with a 3--day medical history of wheal symptoms; 3.An UAS score of at least 4 points as assessed by the investigator before randomization; 4.Willing to sign an informed consent form, able to understand the requirements for completing a diary card, and able to record daily symptoms in a timely and truthful manner during the study period, and willing to cooperate to complete the trial in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria: Known allergy to omalizumab, excipients of the study drugs, or other biosimilars, or a history of severe drug allergy or anaphylactic shock; 2.Use of the following medications before enrollment without completing the required washout period: Regular systemic corticosteroid use (for at least 5 consecutive or alternate days) with a washout period of 45 days; 3.Regular immunosuppressant use (e.g., methotrexate, cyclosporine, cyclophosphamide, tacrolimus, or triptolide, for at least 5 consecutive or alternate days) with a washout period of 45 days; 4.Topical medications (e.g., corticosteroids) with a washout period of 14 days; 5.Traditional Chinese medicine or Chinese patented medicines for urticaria, or those containing ingredients that may treat urticaria (e.g., Yupingfeng Granules, Fangfeng Tongsheng Pills, Fuyang Granules, Kuyin Pills, Xiaofeng Zh yang Particles, Fufang Qingdai Pills, Urticaria Pills, Jinchuan Zh yang Capsules, or Danggui Kucen Pills) with a washout period of 30 days; 6.Presence of any clinically significant unstable diseases: High--risk severe ventricular arrhythmias, such as marked left ventricular dysfunction, NYHA Class III/IV heart function, a history of familial long QT syndrome, or a family history of torsades de pointes; 7.Myocardial infarction within 6 months before screening, unstable angina pectoris, a history of acute coronary syndrome, or other high--risk coronary artery disease; 8.Poorly controlled hypertension (defined as a diagnosis of Grade 2 or higher hypertension with high--risk stratification, and despite taking one or two antihypertensive drugs, systolic blood pressure is still =160 mmHg and/or diastolic blood pressure is =100 mmHg); 9.Presence of other chronic pruritic skin diseases that may affect the assessment of study outcomes, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or senile pruritus; 10.Presence of other diseases presenting with urticarial wheals or angioedema, such as drug--induced urticarial drug eruptions, urticarial vasculitis, or adult--onset Still's disease; 11.Presence of angioedema at randomization; 12.Investigator considers that the subject has other conditions that make participation in the study unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UAS Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event,AE;The proportion of patients without angioedema;Proportion of patients with a UAS score of 0;DLQI Score; | — |
Countries
China
Contacts
Public ContactZhang Guoqiang
The first hospital of hebei medical university
Outcome results
None listed