NCT04805411

Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

A Randomized, Double Blind, Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.

Detailed description

Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.

Conditions

• Moderate-to-severe Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	CM310	IL-4Rα monoclonal antibody
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-11-08
• Completion: 2021-11-08
• First posted: 2021-03-18
• Last updated: 2022-04-15

Locations

25 sites across 1 country: China