NCT07372287

A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.

Conditions

• Moderate to Severe Asthma

Interventions

Type	Name	Description
DRUG	CM326	subcutaneous injection
OTHER	Placebo	subcutaneous injection

Timeline

• Start date: 2026-01-26
• Primary completion: 2028-12-31
• Completion: 2029-03-31
• First posted: 2026-01-28
• Last updated: 2026-01-28