NCT05265923

A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.

Detailed description

The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	CM310	IL-4Rα monoclonal antibody
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-04-22
• Primary completion: 2023-10-31
• Completion: 2023-12-25
• First posted: 2022-03-04
• Last updated: 2024-11-08

Locations

1 site across 1 country: China