Phase
Condition
Hives (Urticaria)
Urticaria
Treatment
Omalizumab
JYB1904
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female adult subjects (≥18 years of age).
Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 -
- ≥ 6 within 7 days prior to randomization.
Exclusion
Exclusion Criteria:
Induced urticaria with a defined trigger, including artificial urticaria (cutaneousscratches), cold-contact, heat-contact, solar, pressure, delayed-pressure,water-source, cholinergic, or contact urticaria
Any other dermatological condition with chronic itching, such as atopic dermatitis,herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in theopinion of the investigator may affect the study assessment and study results
Other conditions with symptoms of urticaria or angioedema, including but not limitedto urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis,hereditary urticaria, or acquired/drug-induced urticaria.
Previous allergic reaction or poor efficacy with omalizumab.
Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine,loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or anyof the ingredients.
Study Design
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting

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