A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

This is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Children's Hospital Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

12 years ≤ age ≤ 18 years
With atopic dermatis
Voluntarily sign the informed consent form

Exclusion criteria

Weight < 30 kg
Major surgery planed during the study

Treatment and study plan

CM310

Biological

CM310 600 mg + 300 mg, subcutaneous injection

Primary outcomes

Adverse events

Time frame: at week 14

Incidence of adverse events.

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Oct 14, 2022
Registry last updated: Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed