NCT07402213

Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Jemincare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

Detailed description

This study is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with CSU inadequately controlled by second-generation H1 antihistamines.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	JYB1904	300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.
DRUG	Placebo+JYB1904	Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-06-30
• Completion: 2028-04-28
• First posted: 2026-02-11
• Last updated: 2026-02-11