Phase II Study of CM512 Injection for Treating Chronic Spontaneous Urticaria in Adults Aged 18 to 75

What this Trial Is About

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate CM512 injection in adults with Chronic Spontaneous Urticaria CSU. The study aims to assess the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in people who have had CSU for at least six months and continue to experience symptoms despite antihistamine treatment. Participants will receive either CM512 injection or a placebo via subcutaneous injection. All participants must be on a stable dose of second-generation H1-Antihistamines before and during the study. The treatment period lasts up to 16 weeks, during which researchers will monitor changes in urticaria activity scores to evaluate treatment effects. During the study, participants will undergo regular assessments of their urticaria activity using a 7-day score UAS7. Safety and other response measures will be monitored, including any allergic reactions or side effects. The total participation involves screening, treatment, and follow-up visits over the treatment duration to carefully observe the impact of CM512 compared to placebo.

Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU)