A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Yila Sha
shayila@jemincare.com
86-021-52887926
Time Frame
Start Date: 2024-08-04
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 135
Treatments
Experimental: JYB1904: Dose-1
Experimental: JYB1904: Dose-2
Active_comparator: Omalizumab
Related Therapeutic Areas
Sponsors
Leads: Jemincare