Actively Recruiting
Trial of JYB1904 in Chronic Spontaneous Urticaria.
Led by Jemincare · Updated on 2024-11-29
135
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
CONDITIONS
Official Title
Trial of JYB1904 in Chronic Spontaneous Urticaria.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adult subjects (≥18 years of age)
- Diagnosis of Chronic Spontaneous Urticaria (CSU) for at least 3 months before screening and inadequately controlled with second-generation H1 antihistamines
- Itching and hives lasting 6 weeks or more before screening
- Have a Urticaria Activity Score over 7 days (UAS7) of 16 or higher, an ISS7 score of 6 or higher, and an HSS7 score of 6 or higher within 7 days before randomization
You will not qualify if you...
- Induced urticaria caused by known triggers such as cuts, cold, heat, sunlight, pressure, water, cholinergic, or contact urticaria
- Other chronic itchy skin conditions like atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis that may impact the study
- Other conditions with urticaria or angioedema symptoms, including urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
- Previous allergic reaction or poor effectiveness with omalizumab
- Allergy or sensitivity to antihistamines such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, or bilastine or any ingredients in these drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yila Sha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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