A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

Not Applicable

Not yet recruiting

• Conditions: Atopic Dermatitis
• Interventions: Biological: Stapokibatrt

• Registration Number: NCT07106372
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-09-01
• Primary Completion: 2027-02
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stapokibatrt group	Stapokibatrt	-

Primary Outcome Measures

Name	Time	Method
Adverse events	up to week 44	Incidence of adverse events

Trial Locations

Locations (1)

Beijing Children's Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China