A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

This is a multi-center, single-arm, open-label phase 3 study to evaluate the safety, efficacy, Pharmacokinetics(PK) and immunogenicity of Stapokibatrt in children with Atopic Dermatitis.

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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

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Children's Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location contact

Lin Ma

CONTACT

+86 13601305676

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Voluntarily participate in the continuing study and sign the written Informed Consent Form(ICF).
Subjects who must complete the evaluation of Week 18 of the main study.
Have the ability to communicate well with the researcher and comply with the follow-up visits of the protocol.

Exclusion criteria

Planned major surgical procedure during the patient's participation in this study.
Any other circumstances in which the researcher deems not suitable to participate in this study.

Treatment and study plan

Stapokibatrt

Biological

Stapokibatrt Subcutaneous injection

Primary outcomes

Adverse events

Time frame: up to week 44

Incidence of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Multi-center, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Stapokibatrt in Children With Atopic Dermatitis

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Aug 6, 2025
Registry last updated: Aug 6, 2025

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.

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