Status:
RECRUITING
Trial of JYB1904 in Chronic Spontaneous Urticaria.
Lead Sponsor:
Jemincare
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Eligibility Criteria
Inclusion
- 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 - 21) ≥ 6 within 7 days prior to randomization.
Exclusion
- Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), 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 the opinion of the investigator may affect the study assessment and study results
- Other conditions with symptoms of urticaria or angioedema, including but not limited to 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 any of the ingredients.
Key Trial Info
Start Date :
August 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06509334
Start Date
August 4 2024
End Date
July 15 2026
Last Update
November 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044