Phase II Study of JYB1904 Injection to Treat Adults With Chronic Spontaneous Urticaria Not Controlled by H1 Antihistamines

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of JYB1904 injection in adult patients with chronic spontaneous urticaria who have not been adequately controlled by second-generation H1 antihistamines. This Phase II clinical trial aims to understand how well JYB1904 works in managing this condition compared to an active comparator, Omalizumab, with a focus on reducing symptoms such as itching and hives. Participants will be randomly assigned to one of three groups one receiving JYB1904 at week 0 followed by placebo at weeks 4, 8, and 12 another receiving JYB1904 at weeks 0 and 8 with placebo at weeks 4 and 12 and a third group receiving Omalizumab every 4 weeks for a total of 12 weeks. This parallel-group, double-blind study will carefully monitor treatment effects over a period extending up to 32 weeks. Throughout the study, participants will track their urticaria activity using scores for itching, hives, and angioedema recorded over seven consecutive days at various time points. Quality of life will also be assessed using a dermatology-specific index. Researchers will monitor safety, tolerability, and immune response markers such as immunoglobulin E and anti-drug antibodies. The total participation duration accommodates baseline through 32 weeks of observation and follow-up.

Trial of JYB1904 in Chronic Spontaneous Urticaria.