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

This is a multi-center, single arm, open-label study to evaluate safety 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

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / 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

With atopic dermatis.
Voluntarily sign the informed consent form.

Exclusion criteria

Any major surgery planned during the research period.
With intestinal parasitic infection within the first 6 months of screening.
With any previous malignant tumors prior to screening.
With any circumstance that is not suitable to participate in this study.

Treatment and study plan

CM310

Biological

CM310 injection

Primary outcomes

Adverse events

Time frame: up to week 16

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 Children Subjects With Moderate-to-severe Atopic Dermatitis

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Dec 8, 2023
Registry last updated: Oct 15, 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